Parexel, a global leader in clinical research and regulatory consulting, is hiring talented professionals in Regulatory Affairs for its Bengaluru, India office. If you’re passionate about global compliance, life cycle management, and pharmaceutical labeling, this is your opportunity to advance your career with one of the world’s most respected healthcare organizations.
Parexel offers a purpose-driven culture where every contribution helps improve global health outcomes.
💼 Available Positions at Parexel
1️⃣ Senior Regulatory Affairs Associate (Labelling)
Location: Bengaluru, India
Experience: 4–6 years
Key Responsibilities
- Develop and maintain labeling documents (CCDS, USPI, packaging).
- Manage label updates, compliance, and governance across global markets.
- Coordinate artwork approvals and maintain artwork systems.
- Author and review labeling lifecycle submissions (PSUR, post-approval).
- Collaborate with supply chain and quality teams for packaging compliance.
- Use RIMS platforms like Veeva, TVT, or Docubridge for regulatory documentation.
Required Qualifications
- Bachelor’s or Master’s in Pharmacy, Science, or Life Sciences.
- 4–6 years of experience in global regulatory labeling and artwork management.
- Strong knowledge of US, EU, and other regional labeling regulations.
- Proficiency in SPL, eDMS, and post-approval labeling management.
2️⃣ Senior Regulatory Affairs Associate (Biologics/Small Molecules)
Location: Bengaluru, India
Experience: 4–6 years
Key Responsibilities
- Handle life cycle management of small molecules and biologics.
- Author CMC components for MAAs, variations, and renewals.
- Address CMC-related Health Authority queries and submissions.
- Conduct regulatory impact assessments for EU/US markets.
- Collaborate cross-functionally and maintain RIMS systems (Veeva Vault).
- Review labeling content (EU, Canada, AU/NZ & US) per CCDS/PRAC guidelines.
Required Qualifications
- M.Pharm / B.Pharm / M.Sc in Life Sciences or related discipline.
- 4–6 years of regulatory experience in Biologics or Small Molecules.
- Strong knowledge of ICH guidelines, EU/US procedures, and GMP submissions.
- Experience in DMF, stability, and CMC dossier preparation.
3️⃣ Regulatory Affairs Consultant (Biologics/Small Molecules)
Location: Bengaluru, India
Experience: 7–10 years
Key Responsibilities
- Lead global regulatory maintenance submissions (EU/US/ROW).
- Author and review CMC components for IND, NDA, BLA, and MAA filings.
- Conduct regulatory gap analysis and remediation strategies.
- Manage labeling and artwork updates, ensuring global compliance.
- Mentor team members and liaise with internal/external stakeholders.
Required Qualifications
- Advanced degree in Pharmacy, Life Sciences, or Chemistry.
- 7–10 years’ experience in regulatory life cycle management.
- Expertise in global submission procedures and HA interactions.
- Skilled in RIMS platforms (Veeva Vault) and artwork coordination.
🎯 Why Join Parexel?
- Work with a globally respected CRO and regulatory consulting leader.
- Competitive salary and performance-linked bonuses.
- Exposure to international health authority submissions (FDA, EMA, TGA).
- Collaborative, inclusive work culture.
- Opportunities for global career growth and professional development.
📝 How to Apply
Application Link for Senior Regulatory Affairs Associate (Labelling)
Application Link for Senior Regulatory Affairs Associate (Biologics/Small Molecules)
Application Link for Regulatory Affairs Consultant (Biologics/Small Molecules)
