Location: Pune, Maharashtra, India (WeWork – On-site)
Job Type: Full-Time
Application Deadline: May 15, 2026
Job Requisition ID: R391846
Company: Merck & Co., Inc.
About the Company
Merck & Co., Inc. is a globally recognized leader in healthcare and animal health, committed to advancing science for healthier lives. With a strong global footprint across more than 50 countries, the organization delivers innovative veterinary pharmaceuticals, vaccines, and health management solutions, contributing to global food safety and animal well-being.
Job Overview
The Associate Director, Regulatory Affairs will lead regulatory strategy, product registration, and compliance for pharmaceutical and biological products in the Indian and global markets. This role requires deep expertise in regulatory frameworks, dossier development, and cross-functional leadership to ensure timely approvals and sustained compliance across product lifecycles.
Experience Required
15+ years of relevant experience in Regulatory Affairs within the pharmaceutical, biological, or veterinary healthcare domain
This is a senior leadership role and is not suitable for freshers
Key Responsibilities
Lead regulatory strategy for registration of imported pharmaceuticals, vaccines, and locally manufactured biological products
Oversee development, submission, and lifecycle management of CTD dossiers for India and global export markets
Ensure compliance with Indian regulatory requirements, GMP, manufacturing, wholesale licensing, and internal compliance policies
Manage approvals for artworks, labeling, and packaging in alignment with country-specific regulations
Coordinate with regulatory authorities for product approvals, renewals, and compliance-related submissions
Drive regulatory support for clinical trials, CDTL testing, and toxicity studies in collaboration with internal and external stakeholders
Maintain regulatory archives, documentation systems, and audit readiness in accordance with ISO, EHS, and OHSAS standards
Collaborate with cross-functional teams including Marketing, Clinical, Quality Control, and Technical departments
Lead and mentor Regulatory Affairs team members, ensuring performance, development, and process excellence
Identify strategic opportunities for new product development and market expansion through regulatory gap analysis
Build and maintain strong relationships with regulatory authorities, industry forums, and key opinion leaders
Support global regulatory alignment by coordinating with international regulatory teams
Regulatory & Technical Expertise Required
Strong experience in Common Technical Document (CTD) preparation and regulatory submissions
Expertise in pharmaceutical and biological product registration for domestic and export markets
Knowledge of Indian regulatory authorities and global regulatory frameworks
Experience in regulatory compliance, audits, and documentation control systems
Understanding of clinical trial regulations, toxicity studies, and product lifecycle management
Qualifications
BVSc & AH or equivalent Life Sciences qualification
Postgraduate qualification (e.g., PGDMM) preferred
Strong domain knowledge in veterinary pharmaceutical regulations and market landscape
Key Skills & Competencies
Regulatory Affairs Strategy and Leadership
Drug Registration and Regulatory Submissions
Cross-functional Collaboration and Stakeholder Management
Strategic Thinking and Market Expansion Planning
Team Leadership and People Development
Strong communication and networking skills across regulatory bodies and global teams
Why This Role Matters
This position offers an opportunity to lead regulatory excellence in a globally respected organization, directly contributing to product innovation, compliance, and market expansion in the animal health sector. The role plays a strategic part in ensuring safe, effective, and compliant healthcare solutions reach global markets.
Important Note for Applicants
This is a senior-level Regulatory Affairs leadership role requiring extensive industry experience. Candidates at entry-level or early career stages should explore roles such as Regulatory Affairs Executive or Associate positions before progressing to leadership roles like Associate Director.
How to Apply
Apply through the official careers portal of Merck & Co., Inc. or explore more verified global opportunities on ThePharmaDaily.com.
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Sheffield |Oxfordshire :
Witney |Ontario :
Renfrew | Australia | Uxbridge | North York | Mississauga | Richmond Hill |Canada :
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Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
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Auckland |New Zealand :
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Manila |Croatia :
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