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Parexel, a global leader in clinical research and regulatory solutions, is inviting applications for two key regulatory roles in Bengaluru – Senior Regulatory Affairs Associate (Biologics/Small Molecules) and Regulatory Affairs Consultant (Biologics/Small Molecules).
If you have expertise in regulatory CMC, lifecycle management, and submissions for small molecules, biologics, vaccines, and monoclonal antibodies, this is your opportunity to join a world-class team that helps bring life-saving therapies to patients worldwide.
1. Senior Regulatory Affairs Associate (Biologics/Small Molecules)
Location: Bengaluru, India
Experience Required: 4–6 years
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Key Responsibilities
- Handle life cycle management (LCM) of approved drug products (small molecules, biologics, vaccines, monoclonal antibodies).
- Prepare and review Marketing Authorization Applications (MAA) and variations for EU submissions (DCP/MRP/National).
- Draft documentation for super-grouping, grouping, and work-sharing variations.
- Conduct regulatory review of DMFs, batch records, stability data, and specifications.
- Manage post-approval CMC submissions and respond to health authority queries.
- Prepare and maintain submission delivery plans and provide stakeholder updates.
- Work on labeling content for EU, US, Canada, AU/NZ based on CCDS/PRAC/CMDH.
- Use Regulatory Information Management Systems like Veeva Vault.
Qualifications
- 4–6 years of experience in regulatory affairs (small & large molecules).
- Strong understanding of EU/US regulatory frameworks; knowledge of RoW is an advantage.
- Prior exposure to CMC-related queries and post-approval requirements.
- Strong communication and mentoring skills.
- Familiarity with EU QRD guidelines and excipients.
2. Regulatory Affairs Consultant (Biologics/Small Molecules)
Location: Bengaluru, India
Experience Required: 7–10 years
Key Responsibilities
- Lead and manage biosimilar submissions: IND, IMPD, BLA, MAA for US/EU/ROW/India.
- Prepare and review regulatory gap analysis and strategies for IND, NDA, DMF, BLA submissions.
- Oversee life cycle management: annual reports, renewals, variations (IA/IB/II/IAIN) for EU, US, and RoW.
- Define regulatory strategies for change controls and deviations.
- Collaborate with internal/external stakeholders for regulatory documentation.
- Stay updated with evolving global regulatory guidelines.
- Author and review safety variations, labeling updates, and artwork management.
- Mentor junior team members and ensure compliance with global standards.
Qualifications
- 7–10 years of regulatory affairs experience in biologics/small molecules.
- Proven expertise in BLA/MAA preparation and biosimilar submissions.
- Strong knowledge of EU/US/ROW regulatory pathways.
- Proficiency in Veeva Vault or similar regulatory systems.
- Excellent communication and leadership skills.
Benefits of Working at Parexel
- Work on global submissions impacting patient health worldwide.
- Exposure to biologics, small molecules, biosimilars, and vaccines.
- Collaborative and inclusive work culture.
- Opportunity to mentor and grow within regulatory affairs.
How to Apply
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