Associate Director – Regulatory Affairs (Veterinary)

About the role

The Associate Director, Regulatory Affairs will lead registration activities for both imported and locally manufactured veterinary pharmaceuticals and vaccines in India. This senior position ensures compliance with all applicable laws, internal policies, and international standards while supporting the company’s growth strategy.

Key responsibilities

• Register imported pharmaceuticals, vaccines and local biological products for the Indian market.
• Develop and maintain dossiers for export and local markets, including renewal of GMP, manufacturing and wholesale licences.
• Coordinate toxicology studies, clinical trial submissions and ensure regulatory compliance for product approvals.
• Lead interactions with Indian regulatory authorities and represent the company in industry forums.
• Mentor and supervise the regulatory affairs team, establishing processes and managing departmental budgets.
• Maintain archives, implement ISO, EHS and OHSAS standards, and conduct internal audits.

Required profile

• BVSc & AH or related science degree; PGDMM preferred.
• Minimum 15 years of experience in the ethical veterinary market, including product registration and regulatory compliance.
• Proven track record of liaising with government drug authorities and international regulatory teams.
• Strong written and spoken English communication skills.

Required skills

• Common Technical Document preparation.
• Document control systems and electronic submissions.
• International regulatory compliance and drug registration processes.
• Regulatory CMC knowledge.