Nuvo.ai Hiring For Regulatory Affairs

Nuvo.ai is hiring an experienced Regulatory Affairs Executive – 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

• Master’s degree: M.Sc / M.Pharm / M.Tech in
  • Life Sciences
  • Biotechnology
  • Pharmaceutical Sciences or related disciplines
• 3–7 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: ₹12,00,000 – ₹20,00,000 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:

📧 himanshu.ojha@nuvo.ai