Regulatory Affairs Consultant Job at Parexel

Regulatory Affairs Consultant

Join our team and start a new adventure in an international and dynamic environm...

Location

Italy , Latina

Salary:

Not provided

Amaris Consulting

Expiration Date

Until further notice

Requirements

Experience in regulatory affairs with a focus on CMC for sterile pharmaceutical products
Experience in Quality Assurance, specifically in sterility assurance
Experience with Biotech products and API manufacturing is a plus
Experience in preparing and submitting CTD dossiers for the US market (BLA), minimum 10 years
Experience in international registrations (non-CTD) and GMP Clearances/PMF for Asia and Africa markets
Academic background: scientific degree (e.g., Pharmacy, Chemistry, Biology) preferred
Fluent English and Italian
You demonstrate strong analytical and communication skills

Job Responsibility

Prepare and review regulatory dossiers in CTD format for the US market (BLA)
Manage regulatory submissions and communications for sterile products, including Biotech and API manufacturing
Oversee international product registrations, including non-CTD formats and GMP Clearances/PMF for Asia and Africa markets
Ensure compliance with global regulatory requirements for sterile pharmaceutical products
Collaborate with Quality Assurance teams, focusing on sterility assurance
Support regulatory strategy development for new and existing products
Liaise with cross-functional teams to gather and validate documentation for regulatory submissions
Monitor and interpret changes in regulatory guidelines impacting sterile and biotech products

What we offer

An international community, bringing together 110+ different nationalities
An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
A robust training system with our internal Academy and 250+ available modules
A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support

Fulltime

Regulatory Affairs Consultant

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

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

4–6 years of CMC regulatory experience in the pharmaceutical industry for a Consultant level role, 7+ years for a Senior Consultant
Proven success in preparing regulatory documentation for FDA, EMA, and Health Canada (IND, NDA, DMF)
In-depth understanding of drug development, manufacturing processes, GMP, and regulatory frameworks for small molecules and biologics
Strategic and proactive mindset with strong operational execution
Excellent analytical, problem-solving, and negotiation skills
Effective communicator with strong interpersonal, presentation, and leadership abilities
Ability to manage multiple projects independently in a matrixed, multicultural environment
Proficiency in Microsoft Office Suite and regulatory systems
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or related field
Advanced degrees (Pharm.D., M.S., Ph.D.) in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology, or Biology preferred

Job Responsibility

Provide regulatory strategy input for small molecule and biologic products
Support regulatory leads in developing contingency plans for CMC-related scenarios
Represent CMC Regulatory Affairs in cross-functional project meetings and provide regulatory guidance in collaboration with global regulatory leads
Prepare, coordinate, and review CMC and GMP-related documents for regulatory submissions
Develop CMC strategies for products across all phases—from early development to marketing applications and post-approval changes
Partner with manufacturing, quality, and external organizations to address CMC-related issues
Maintain collaborative relationships with internal stakeholders, affiliates, contract manufacturers, packagers, and suppliers
Support planning and execution of Health Authority meetings, including mock sessions
Identify and implement process improvements to enhance regulatory efficiency and readiness
Participate in monthly CMC Global Regulatory Team meetings to align strategies across functions

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Fulltime

New

Senior Regulatory Affairs Consultant - Regulatory Labeling Strategist

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

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

5-7 years in biotech/pharmaceutical industry
2+ years in global labeling/regulatory with global strategic leadership responsibilities
Proven ability to lead cross-functional teams and influence stakeholders across diverse cultural and geographic settings
Strong knowledge of US, EU, DE, CH, AU regulatory labeling lifecycle management
Experience with direct-to-consumer advertising, social media review, and Health Authority negotiations
Must be familiar and able to work with RIMS (e.g., Veeva RIMS), eDMS (e.g., Veeva), Apollo, Docubridge, and Change Management systems (e.g., Trackwise)
Experience with Microsoft Office applications, SharePoint, Adobe Acrobat, TVT, Promomats, and GLAMS
Knowledge of regulatory requirements relevant to drug development, global labeling, and post-marketing (US, EU, AU, DE preferred)
Demonstrated problem-solving ability with risk analysis and sound decision-making
Strong collaboration skills, with experience working in global, cross-cultural, matrix environments

Job Responsibility

Define and drive global labeling strategy across foundational and non-foundational markets (US, EU, AU, CH, DE)
Lead creation, revision, and management of core labeling documents, including Core Data Sheet (CDS), USPI, EU SmPC, Global Patient Leaflet, and Target Label Profile
Align labeling content and strategy across U.S., EU, and global regulatory teams
facilitate timely endorsement of labeling decisions by senior leadership
Interpret clinical and scientific data to inform labeling content and product claims
identify strategic risks and opportunities
Remain current with global labeling regulations and provide training to internal stakeholders
Chair and manage Labeling Review Committee (LRC), Global Labeling Committee (GLC), and CCDS Working Team—set agendas, drive decisions, and ensure timely implementation
Develop and maintain governance frameworks for company positions (DLS, CCDS, USPI, EU SmPC) and foundational markets
Influence external labeling landscape through policy intelligence and strategic engagement

Fulltime

Regulatory Affairs Consultant- Regulatory Partner Responsible

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

Location

India , Bengaluru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

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

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

What we offer

Flexible work arrangements

Senior Regulatory Affairs Consultant - Regulatory Intelligence

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

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

At least 5-7 years of regulatory affairs experience to include previous regulatory intelligence experience
Knowledge of FDA regulations as well as an understanding of the Summary basis of approval and labeling is helpful
A minimum of a bachelor’s degree in a scientific or technical discipline, advanced degree preferred
Project management / leadership experience
Excellent interpersonal and intercultural communication skills, both written and verbal
Client-focused approach to work (Quality)
Results orientation
Teamwork and collaboration skills
Consulting skills
Critical thinking and problem-solving skills

Job Responsibility

Regularly search the public domain for new and updated regulations and regulatory guidance documents that can impact the client’s development programs, and report the most critical findings
Regularly search the public domain for competitor product regulatory developments and report the most critical findings
Inform client immediately of any changes to the regulatory environment directly affecting client’s business
Search for non-compliance letters or notices for client’s suppliers and provide a regular report
Perform ad hoc research on specific regulatory topics at client’s request, using the internet and various subscription database tools
Identify public commenting opportunities for draft guidances/regulations and coordinate review and comments from client. Lead the client’s internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities.
Maintain a list of upcoming regulatory meetings/workshops/conferences pertinent to client
Support Regulatory Intelligence activities, including the use of Cortellis, Citeline, WebWatcher. This includes tracking, coordinating and participating in ad hoc searches as well as scheduled activities.

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

New

Regulatory Affairs Consultant – Compliance & Process

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

Location

Poland , Warsaw

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Bachelor's degree in Life Sciences, Pharmacy, Biotechnology, Engineering, or related field
8+ years in Regulatory Compliance, Quality Assurance, or related GxP functions in pharma/biotech
Strong knowledge of FDA, EMA, ICH, and global GxP regulations
Experience supporting regulatory inspections and audit management
Hands-on experience with controlled document management and eDMS platforms
Experience with GxP training governance and learning management systems
Strong analytical, communication, and stakeholder management skills
Ability to manage multiple priorities in fast-paced environments
Fluent in English written and spoken

Job Responsibility

Serve as SME for controlled document management, ensuring compliant governance and inspection readiness
Author, review, approve, and manage controlled procedures and quality documents per GxP requirements
Drive document lifecycle management activities including creation, revision, periodic review, and archival
Provide guidance on procedural writing standards and document management best practices
Support GxP training governance to ensure compliance with regulatory requirements
Maintain effective training curricula aligned with role-based responsibilities and procedural updates
Monitor training compliance metrics and support remediation of non-compliant records
Support inspection readiness activities related to training documentation and personnel qualification
Lead regulatory compliance activities across global GxP operations
Drive inspection readiness initiatives and support FDA, EMA, MHRA, and other health authority inspections

What we offer

Flexible work arrangements
Supportive and inclusive environment
Opportunities for career growth
Diverse and global client exposure
Learn from experts

Fulltime

New

Senior Regulatory Affairs Consultant

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Extensive experience in managing new registrations, life cycle maintenance, and renewals for biological products including vaccines, recombinant proteins, monoclonal antibodies, and plasma‑derived therapies across major markets such as the US, EU, Japan, Canada, Switzerland and Australia
Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective
Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia
Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries
Strong communication and collaboration skills, ability to work independently
The role is for a team lead with expectations to guide/mentor team members on technical aspects including regulatory filings to global markets
Experience level: 10 to 14 years of relevant experience
Minimum of a bachelor’s degree in a Scientific or Technical Discipline, Advanced Degree preferred

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

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