CrawlJobs Logo

Regulatory Affairs Consultant- Regulatory Partner Responsible

parexel.com Logo

Parexel

Location Icon

Location:
India , Bengaluru

Category Icon
Category:
Consulting

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided
Save Job
Save Icon
Apply Position

Job Description:

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Job Responsibility:

  • Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards
  • monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly
  • Conduct periodic assessments of partners to ensure compliance with local requirements and quality standards, implement corrective actions as necessary
  • develop risk mitigation strategies and implement controls to minimize risks associated with partner activities. Act as point of contact for escalations and issue resolution related to partner activities
  • Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team
  • participating in policy activities with industry groups and trade associations
  • Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs
  • Keep internal databases up to date with local activity and ensure compliance KPIs are adequately kept on track
  • Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with Has
  • Monitor training effectiveness and compliance, ensure proper trainings are developed and in place, providing support and resources as needed to address gaps and improve performance

Requirements:

  • Ideally 5+ years of experience in Regulatory Affairs, oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry
  • Partner management experience: proven experience in managing relationships with third-party vendors
  • Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive
What we offer:

Flexible work arrangements

Additional Information:

Job Posted:
May 14, 2026

Work Type:
Remote work
Icon
Parexel - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Regulatory Affairs Consultant- Regulatory Partner Responsible

Senior Manager, Regulatory Affairs

The mission of the Regulatory Affairs group is to implement effective processes ...
Location
Location
United States , St Louis
Salary
Salary:
122187.50 - 158125.00 USD / Year
steris.com Logo
STERIS
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree
  • 7 years of Regulatory Affairs experience
  • Minimum of 7 years of US EPA Antimicrobial registration experience
  • US State Registration experience
  • Leadership experience managing a team of people
  • Ability to travel as noted above
Job Responsibility
Job Responsibility
  • Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compliance requirements for marketing STERIS products in their assigned areas or regions where STERIS does business
  • Effectively interface with government agencies, notified bodies, consultants and authorized dealer representatives as necessary to address registration related issues. Act as person responsible for regulatory compliance as assigned by upper management
  • Provide regulatory guidance and support to project teams and STERIS internal Customers to support new product development and existing product lines in support of registration requirements.
  • Develop sound global regulatory strategies for new products. Identify and communicate applicable regulatory requirements to STERIS Regulatory Affairs management and the department’s business partners from the start of product development through qualification testing and submission/registration, and as changes occur or new requirements are identified.
  • Gather information and documentation on new or modified products to determine submission requirements for particular markets.
  • Compile and create document registration packages through analysis and synthesis in a standardized format to support product claims and satisfy regulatory authorities.
  • Critically assess the strength and completeness of documentation created by others
  • advise improvements to comply with current requirements for particular regulatory authorities.
  • See that all direct team members maintain submission documents and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information.
  • Report to management concerning current, pending, and re-registration approvals. Identify and take action on any unexpected delays
What we offer
What we offer
  • Market Competitive Pay
  • Extensive Paid Time Off and (9) added Holidays
  • Excellent Healthcare, Dental and Vision Benefits
  • Long/Short Term Disability Coverage
  • 401(k) with a company match
  • Maternity and Paternity Leave
  • Additional add-on benefits/discounts for programs such as Pet Insurance
  • Tuition Reimbursement and continued education programs
  • Excellent opportunities for advancement in a stable long-term care
  • Fulltime
Read More
Arrow Right

Senior Regulatory Affairs Consultant

As part of Parexel Consulting, you will play a vital role in helping biopharmace...
Location
Location
Malaysia
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Fluent in local language, English, oral and written
  • Expert MS Office skills
  • Excellent organizational, time management and interpersonal skills in a global environment
  • Ability to work successfully in a complex global matrix organization
  • Proven ability to work effectively both independently and in a team
  • The expertise, determination and courage to resolve or escalate issues as appropriate
  • Subject matter expert in job area typically obtained through advanced education and work experience
  • Ideally 5+ years of experience in Regulatory Affairs, oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry
  • Partner management experience: proven experience in managing relationships with third-party vendors
  • Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive
Job Responsibility
Job Responsibility
  • Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards
  • monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly
  • Conduct periodic assessments of partners to ensure compliance with local requirements and quality standards, implementing corrective actions as necessary
  • develop risk mitigation strategies and implement controls to minimize risks associated with partner activities
  • Act as point of contact for escalations and issue resolution related to partner activities
  • Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team
  • participating in policy activities with industry groups and trade associations
  • Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs
  • Keep internal data bases up to date with local activity and ensure compliance KPIs are adequately kept on track
  • Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with HAs
What we offer
What we offer
  • Flexible work arrangements
  • Fulltime
Read More
Arrow Right

Director of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...
Location
Location
United States , Cambridge
Salary
Salary:
Not provided
life-science-talent-solutions.dk Logo
Life Science Talent
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in a scientific subject area coupled with sufficient industry experience
  • Advanced degrees (e.g. MSc, PhD, PharmD, MD) preferred
  • 8+ years of pharmaceutical industry experience
  • 6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience
  • Experience in rare diseases, especially rare hematological disorders, preferred
  • Understands and works effectively with team members and consultants to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations
  • Ability to advise on applicable regulations and guidance documents
  • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects
  • Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science
  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability
Job Responsibility
Job Responsibility
  • Develop and execute innovative global regulatory strategies for the global development of candidates for the treatment of rare, hematological disorders
  • Define, develop, and lead execution of strategies to maximize global regulatory success and achieve program objectives for complex development projects in the rare disease space
  • Keep abreast of new developments in regulatory science and maintain oversight on the evolving regulatory landscape and advancing innovations
  • Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects
  • Lead, contributing to cross-functional initiatives and influencing the field
  • Represent Hemab in industry/regulatory forums to lead regulatory innovation
  • Responsible for complex and potentially multiple projects within the Rare Disease space
  • Responsible for development of regulatory strategies related to development and licensure of biologic development products
  • Represents Regulatory Affairs at project team meetings
  • Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions
  • Fulltime
Read More
Arrow Right

Director of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...
Location
Location
United States , San Francisco Bay Area
Salary
Salary:
Not provided
life-science-talent-solutions.dk Logo
Life Science Talent
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in a scientific subject area coupled with sufficient industry experience
  • Advanced degrees (e.g. MSc, PhD, PharmD, MD) preferred
  • 8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience
  • Experience in rare diseases, especially rare hematological disorders, preferred
  • Understands and works effectively with team members and consultants to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations
  • Ability to advise on applicable regulations and guidance documents, including providing interpretation of these governing documents by regulators as experience is gained in practice
  • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy
  • Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science
  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability
  • Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally
Job Responsibility
Job Responsibility
  • Develop and execute innovative global regulatory strategies for global development of candidates for treatment of rare, hematological disorders
  • Define, develop, and lead execution of strategies to maximize global regulatory success and achieve program objectives for complex development projects in the rare disease space
  • Keep abreast of new developments in regulatory science and maintain oversight on evolving regulatory landscape and advancing innovations
  • Understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy
  • Contribute to cross-functional initiatives and influence the field
  • Represent Hemab in industry/regulatory forums to lead regulatory innovation
  • Responsible for complex and potentially multiple projects within the Rare Disease space
  • Development of regulatory strategies related to development and licensure of biologic development products
  • Represent Regulatory Affairs at project team meetings
  • Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions
  • Fulltime
Read More
Arrow Right

Senior Regulatory- Labelling

Join Our Team as a Regulatory Affairs Labelling Expert! Are you ready to make a ...
Location
Location
Salary
Salary:
Not provided
cencora.com Logo
Cencora
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Language Proficiency: Fluent business English (or native English), with additional EU language skills as a plus
  • Educational Background: A degree in pharmacy, medicine, life sciences, or a bachelor’s degree in science
  • Regulatory Affairs Expertise: Proven experience in regulatory affairs with a strong track record in labelling activities for innovator drugs on a global level
  • Lifecycle Management: Experience in handling marketing authorizations and their lifecycle management
  • Regulatory Knowledge: Sound understanding of pharmaceutical and regulatory requirements in the EU and ideally in one ICH region
  • Technical Skills: Affinity for databases, labelling software tools, and project management software, with the ability to monitor and adhere to timelines
  • Personal Attributes: Team player with excellent communication skills, conscientious, accurate, and responsible
  • Software Proficiency: Confident in using MS Excel, MS Word, databases, and document management systems
Job Responsibility
Job Responsibility
  • Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling) in EU and also for non-EU markets, preferably including development of target product/labelling profiles
  • Manages creation and maintenance of CCDS/CCSI/RSI, as applicable, in direct collaboration with relevant departments/expert functions responsible for CCDS section content (e.g. from medical, safety department)
  • Ensures communication to internal / external stakeholders regarding new and updated CCDSs and Product Information
  • Escalates deviation and compliance issues to the labelling governance bodies (e.g. Safety monitoring committee, Global labelling boards) as necessary
  • Experience in labelling documentation and informative texts for innovator drugs on a global (headquarter) level
  • Planning and expediting the approval projects using the internally available or client-based software tools including databases and document management systems
  • Providing regulatory expertise to regulatory programs and projects as well as to clients
  • General guidance (consultancy) of Cencora staff and customers regarding Regulatory Submissions & Labelling activities including also updates on new trends and/or changes in legislation
  • Creation, revision, editing and maintenance of regulatory documentation
  • Professional interaction with clients and Health Authorities
  • Fulltime
Read More
Arrow Right

Director of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...
Location
Location
Sweden , Greater Malmö Metropolitan Area
Salary
Salary:
Not provided
life-science-talent-solutions.dk Logo
Life Science Talent
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in a scientific subject area coupled with sufficient industry experience
  • 8+ years of pharmaceutical industry experience
  • 6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience
  • Experience in rare diseases, especially rare hematological disorders, preferred
  • Understands and works effectively with team members and consultants to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations
  • Ability to advise on applicable regulations and guidance documents
  • Understands and interprets scientific data as it relates to regulatory requirements and strategy
  • Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science
  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability
  • Demonstrates acceptable skills with increasing independence in the area of regulatory strategy
Job Responsibility
Job Responsibility
  • Develop and execute innovative global regulatory strategies for the global development of candidates for the treatment of rare, hematological disorders
  • Define, develop, and lead execution of strategies to maximize global regulatory success and achieve program objectives for complex development projects
  • Keep abreast of new developments in regulatory science and maintain oversight on the evolving regulatory landscape and advancing innovations
  • Understand and interpret scientific data as it relates to regulatory requirements and strategy
  • Represent Regulatory Affairs at project team meetings
  • Collaborate across technical functions to create innovative regulatory strategies and pragmatic solutions
  • Effectively communicate regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders
  • Proactively anticipate regulatory risks and develop mitigation strategies
  • Be accountable for all Regulatory Agency submissions and approvals, overseeing outsourced vendors and/or internal team members
  • Be the direct point of contact with health authorities, lead and manage Regulatory Agency meetings
  • Fulltime
Read More
Arrow Right

Senior Global CMC Manager (Development & Lifecycle)

Karo Healthcare, a dynamic and growing personal-care retail company, is all abou...
Location
Location
Sweden , Stockholm
Salary
Salary:
Not provided
life-science-talent-solutions.dk Logo
Life Science Talent
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in Life Sciences
  • Strong understanding of regulatory requirements and applicable legal frameworks for pharmaceutical products
  • Proven CMC expertise covering the full product lifecycle, including post-approval development and manufacturing-related changes
  • Extensive experience in variation management, including the development and execution of regulatory and CMC strategies
  • Experience with EU regulatory procedures (primarily national, as well as DCP and MRP), with exposure to additional markets considered an advantage
  • Demonstrated experience working at the interface between Regulatory CMC, R&D CMC, and Manufacturing for commercialised pharmaceutical products
  • Hands-on experience with CMC Module 3 authoring, review, and lifecycle maintenance
  • Solid understanding of pharmaceutical manufacturing processes, formulation principles, APIs, and CMO-based supply models
  • Proven ability to work cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Commercial functions, and external partners
  • Experience interacting with regulatory authorities and maintaining effective professional relationships
Job Responsibility
Job Responsibility
  • Act as global CMC Module 3 owner throughout the product lifecycle, ensuring scientific consistency and alignment with the actual manufacturing processes, formulation, APIs, control strategies, and implemented post-approval changes
  • Manage and maintain the CMC (Module 3) components of global and local dossiers, including technical preparation and compilation of CMC documentation to support regulatory submissions and lifecycle maintenance, with particular responsibility for legacy products
  • Ensure timely implementation of approved CMC changes within defined scope, including verification that Module 3 documentation and internal systems reflect Health Authority approvals
  • Assess and lead regulatory CMC evaluation of proposed changes, including technical impact assessment, variation classification, and identification of required documentation in alignment with applicable EU and relevant market requirements
  • Review and approve regulatory CMC documentation for submissions and lifecycle changes in compliance with applicable regulatory requirements and internal regulatory information and document management systems
  • Initiate and maintain CMC-related regulatory events and documentation within the regulatory information management system (e.g., Veeva RIM) in accordance with internal procedures
  • Maintain a current understanding of relevant CMC-related regulations, guidelines, and standards, as well as established and emerging manufacturing and development practices applicable to commercialised pharmaceutical products
  • Lead CMC strategy development for assigned products across development and lifecycle phases, providing aligned CMC input to regulatory strategy discussions, technical risk assessments, gap analyses, and the evaluation and implementation of lifecycle changes
  • Apply in-depth knowledge of CMC Module 3 as a practical lifecycle tool to support and drive technical and regulatory decision-making related to manufacturing and post-approval development activities
  • Act as a technical and regulatory CMC counterpart towards manufacturing CMOs, developing a sound understanding of their manufacturing operations and providing appropriate scientific input, guidance, and challenge as required
What we offer
What we offer
  • Opportunity to create, grow, and encourage
  • Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
  • Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
  • Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
  • Very positive work environment in a dynamic, international, and motivated team
  • Start-up spirit while being a part of the large international organization with strong values
  • Fulltime
Read More
Arrow Right

Associate Director, CMC Regulatory Affairs

Associate Director, CMC Regulatory Affairs (RA) who will work closely with our m...
Location
Location
Canada , Vancouver
Salary
Salary:
141000.00 - 170000.00 CAD / Year
abcellera.com Logo
AbCellera Biologics
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Deep understanding of CMC regulatory requirements, eCTD structure, and Module 3 preparation (BLAs/NDAs/NDSs) for biologics and combination products
  • Ability to navigate regulatory requirements for CMC submissions for biologics and combination products
  • Thorough understanding of Health Canada, FDA, and EMA regulations
  • Ability to efficiently oversee independent contractors and vendors
  • Skilled regulatory writer with effective oral communication skills
  • Detailed oriented, highly organized, and thrives in fast paced environments while managing multiple priorities
  • Relevant post-secondary degree(s) in biological, pharmaceutical, chemical, engineering sciences or a related field
  • About 12 years of relevant work experience
Job Responsibility
Job Responsibility
  • Serving as the primary CMC regulatory representative in project meetings and with regulatory agencies
  • Preparing CMC regulatory submissions including briefing documents, IND submissions, and CTA filings
  • Overseeing the preparation of responses to regulatory authority queries
  • Managing critical CMC regulatory timelines, working with team members to navigate the pathways for manufacturing and analytical development, working in close partnership with the CMC and Quality teams
  • Staying on top of detailed knowledge of the global regulatory environment relevant for biologics, communicating changing regulatory agency requirements, and supporting pertinent regulatory intelligence per needs of programs
  • Collaborating with external consultants, CDMOs, and CROs to provide regulatory guidance
  • Evaluating regulatory CMC program risks and establishing mitigation strategies pertinent to product development
  • Partnering with CMC, Discovery, and Clinical Development teams to innovate strategies to accelerate submission timelines
What we offer
What we offer
  • Equity
  • Annual bonus dependent on team and company performance
  • 6% (non-match) RRSP contribution
  • CAD $1,500 annual Active Lifestyle Allowance
  • Annual vacation
  • Professional development opportunities
  • Comprehensive health benefits
  • Scientific and technical mentorship
  • Fulltime
Read More
Arrow Right