Regulatory Affairs Consultant- Regulatory Partner Responsible Job at Parexel (Bengaluru)

Senior Regulatory Affairs Consultant

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Malaysia

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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

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

Flexible work arrangements

Fulltime

Director of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...

Location

United States , Cambridge

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

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

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

Director of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...

Location

United States , San Francisco Bay Area

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

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

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

Associate Director, CMC Regulatory Affairs

Associate Director, CMC Regulatory Affairs (RA) who will work closely with our m...

Location

Canada , Vancouver

Salary:

141000.00 - 170000.00 CAD / Year

AbCellera Biologics

Expiration Date

Until further notice

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

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

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

Senior Manager, Regulatory Affairs

The mission of the Regulatory Affairs group is to implement effective processes ...

Location

United States , St Louis

Salary:

122187.50 - 158125.00 USD / Year

STERIS

Expiration Date

Until further notice

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

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

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

Director of Regulatory Affairs

Hemab seeks a Director, Regulatory Affairs who will be responsible for developin...

Location

Sweden , Greater Malmö Metropolitan Area

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

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

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

Senior Regulatory Affairs Specialist

New RA position dedicated to the Reusable Pen Platform and its 2 strategic custo...

Location

United States , Franklin Lakes

Salary:

59.00 - 63.00 USD / Hour

MillenniumSoft Inc

Expiration Date

Until further notice

Requirements

Minimum of 5 years of directly related work experience in medical device regulatory field (regulatory submissions, compliance, project management)
Medical device and international registration experience is a must
Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint
Strong project management and communication (verbal, written) and skills
Able to independently handle multiple tasks/projects with minimum supervision
Self-starter with the ability to take over responsibilities
Team player, Attention to details, Highly result-oriented
Flexible and reliable personality
ability to manage stressful situations
High personal integrity and ethical standards

Job Responsibility

Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager
Manage and execute end to end activities, such as documentations, submissions and addressing health authority questions for new or renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market
Maintenance of compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers) in WW market
Performs regulatory impact assessment of changes related to design, improvements and customer experience and coordination of supplement/notification/change submissions for timely implementation
Effective Collaboration with multiple stakeholders i.e. internal teams (PS cross functional, BDX), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada, FDA) for technical requirements and documentation to support regulatory registrations, project deliverables and audit ready folders
Manages multiple projects with attention to detail for health authority submissions and represent RA in internal and external audits by customers and health authorities for compliance to MDSAP, EUMDR, ISO 13485 and global compliance
Identify ways to improve the efficiency of current work process and best practices as necessary.

What we offer

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture and life balance components — is designed to support the varying needs of our diverse associates.

Fulltime

Senior Lead, UK Public Affairs

Shopify is seeking a senior leader to direct our Government Affairs work in the ...

Location

United Kingdom

Salary:

Not provided

Shopify

Expiration Date

Until further notice

Requirements

12+ years of experience in government affairs, public policy, or regulatory advocacy in technology, digital services, payments, ecommerce, or an adjacent sector
Deep understanding of UK government and decision-making process, with an established network across Westminster, Whitehall, and key regulators
Ability to engage directly and credibly with UK government and regulatory stakeholders in line with applicable lobbying and transparency requirements
Demonstrated track record of end-to-end ownership and delivery on high-impact UK policy and advocacy outcomes
Strong data literacy and ability to use research, analytics, and merchant stories to strengthen advocacy
Exceptional written and verbal communication skills
Track record of building strong relationships across government, industry, and civil society to move policy outcomes. Experience managing trade associations and external advisors
Reflexive AI use: you're comfortable leveraging AI tools for drafting, research, and analysis but also know when human judgment, nuance, and stakeholder expertise are essential

Job Responsibility

Develop, lead, and execute Shopify's government affairs and public policy strategy for the United Kingdom, ensuring our priorities are reflected in political, legislative, and public policy initiatives
Be Shopify's lead voice with UK government, Parliament, and the broader policy community: ministers, senior civil servants, MPs, regulators, trade associations, and industry peers
Oversee Shopify's UK trade association memberships and external advisors, keeping advocacy efforts aligned and focused
Lead engagement on priority policy areas affecting Shopify and our merchants, including platform regulation, artificial intelligence, payments and fintech, privacy and data protection, consumer protection, digital trade, and emerging digital policy issues
Coordinate engagement across the UK’s political and regulatory ecosystem, translating Shopify’s policy priorities into relevant government outreach, coalition building, and consultation responses where appropriate
Build strategic engagement with the UK entrepreneurship and SMB ecosystem, enabling founders, retail entrepreneurs, and trade bodies to bring real-world business perspectives into policy discussions affecting commerce and innovation
Develop high-impact, data-driven narratives that translate merchant experience, market realities, and Shopify's strategic priorities into messaging that lands with policymakers
Anticipate regulatory trends, political risks, and policy opportunities
translate them into strategic recommendations that shape Shopify's product, business, and reputation decisions
Brief and advise Shopify's executive team on UK political and regulatory developments and advocacy opportunities

Fulltime

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Regulatory Affairs Consultant- Regulatory Partner Responsible

Job Description

Job Responsibility

Requirements

What we offer

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