Specialist - Regulatory Affairs (Merck)
6/1/20261 min read
Roles and Responsibilities
Your Role:
We are looking for a Regulatory Management Specialist to support regulatory compliance, advocacy, and market access activities in India.
This role will work across internal and external stakeholders to monitor regulatory changes, support product submissions maintain compliance documentation, and represent India regulatory priorities in cross-functional and global discussions.
Monitor and analyze regulatory guidelines, notifications, and gazettes issued by relevant authorities, and assess their impact on business operations
Establish and maintain effective working relationships with key regulatory and government authorities, including CDSCO, IPC, DBT, DAHD, BIS, AQCS, DCPC, and relevant ministries
Drive regulatory engagement and advocacy through active participation in industry associations, including providing input on draft guidelines, seeking clarifications on revised regulations, and addressing compliance gaps proactively
Support regulatory submissions, including import license, test license, NOCs for API, excipients, chemicals, animal by products, cell lines, audits, and compliance documentation
Support new product launches by determining product classification and identifying the most efficient and compliant regulatory pathway
Collaborate cross-functionally to obtain documentation and justifications required for product import, registration, and regulatory query responses
Ensure compliance with applicable standards and regulatory requirements, including WHO-GMP, GLP, Schedule M, and other relevant checklists
Develop, review, and maintain Standard Operating Procedures for the regulatory function
Provide technical and regulatory support to customers and internal stakeholders
Represent India regulatory interests in global regulatory meetings and provide insight on Indian regulatory requirements.
Who You are:
Master’s degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related discipline
Strong understanding of Indian and global regulatory requirements, including CDSCO, IPC, DBT, DAHD, USFDA, EMA, IPEC, PDA and other relevant regulatory or industry bodies
Experience handling regulatory submissions, audits, compliance documentation, and product registration or import-related activities
Good understanding of Pharma and Biopharma manufacturing processes and unit operations
Good understanding of regulatory pathways for new product introduction and lifecycle support such as - API, excipients, chemicals and animal by products, biological origin products etc.
Experience engaging with regulatory authorities, government bodies, or industry associations is preferred
Strong organizational skills and ability to manage multiple priorities in a dynamic environment
Strong written and verbal communication skills
Ability to work effectively in cross-functional teams and influence stakeholders across functions
Willingness to travel domestically up to 10–15%.
Proactive ownership of regulatory topics and timely follow-through on actions.
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