Nuvo.ai is hiring an experienced Regulatory Affairs Executive โ Biologics to support regulatory submissions and lifecycle management across emerging markets. This role is ideal for professionals with hands-on experience in biologics regulatory affairs, including mAbs, biosimilars, vaccines, and advanced therapies.
With increasing global focus on complex biological products, this position offers exposure to IND/BLA submissions, cross-regional regulatory strategy, and alignment with FDA, EMA, ICH, and emerging market frameworks.
Key Responsibilities
- Prepare, review, and manage IND, BLA, and other regulatory submissions for biological products
- Support lifecycle management activities for approved biologics
- Ensure compliance with ICH guidelines, FDA, EMA, and emerging market regulations
- Coordinate regulatory strategies for biosimilars, monoclonal antibodies, vaccines, and novel biologics
- Liaise with cross-functional teams including R&D, QA, and clinical teams
- Track regulatory intelligence and evolving global biologics regulations
Eligibility & Qualifications
- Masterโs degree: M.Sc / M.Pharm / M.Tech in
- Life Sciences
- Biotechnology
- Pharmaceutical Sciences or related disciplines
- 3โ7 years of regulatory affairs experience with a strong biologics focus
- Proven exposure to IND/BLA submissions
- Working knowledge of FDA, EMA, ICH, and emerging market regulatory frameworks
- Experience with biosimilars, vaccines, mAbs, cell & gene therapy is highly preferred
Why Join Nuvo.ai?
- Work on next-generation biologics and advanced therapies
- Exposure to global and emerging market regulatory submissions
- Strong learning curve in biologics lifecycle management
- Competitive compensation aligned with industry standards
- Opportunity to collaborate with experienced regulatory professionals
Salary Details
- Estimated CTC: โน12,00,000 โ โน20,00,000 per annum
(Salary may vary based on experience and regulatory expertise in biologics)
Job Location
- India (Emerging Markets Focus)
- Work mode: Onsite / Hybrid (as per business requirement)
How to Apply
Interested and eligible candidates can send their updated CV / regulatory portfolio to: