Merck Hiring Regulatory Affairs Job | Chemistry Jobs in Mumbai
Looking for a rewarding Regulatory Affairs Job with a global science and technology leader? Merck Careers has announced an excellent opportunity for the position of Specialist – Regulatory Affairs in Mumbai, Maharashtra. This role is ideal for candidates seeking Chemistry Jobs, Life Science Jobs, Biotechnology Jobs, and Pharmaceutical Regulatory Affairs Careers. If you have a passion for regulatory compliance, product registration, and healthcare innovation, this opportunity could be the perfect next step in your professional journey.
About Merck
Merck is a leading global science and technology company dedicated to enriching lives through innovations in Healthcare, Life Science, and Electronics. With a strong focus on research, sustainability, and scientific advancement, Merck empowers employees to drive meaningful change across industries. Through Merck Careers, professionals gain access to a diverse and inclusive workplace that encourages growth, innovation, and collaboration while contributing to solutions that impact millions of people worldwide.
Job Overview
Merck is hiring a Specialist – Regulatory Affairs to support regulatory compliance, advocacy, and market access activities in India. The selected candidate will monitor regulatory changes, support product submissions, maintain compliance documentation, and collaborate with internal and external stakeholders. This Regulatory Affairs
Job involves working with regulatory authorities, supporting new product launches, managing regulatory pathways, and ensuring compliance with applicable pharmaceutical and biopharmaceutical regulations. Candidates interested in Chemistry Jobs, Life Science Jobs, and Biotechnology Jobs will find this role highly valuable for career growth.- Role: Specialist- Regulatory Affairs
- Job ID: 299425
- Location: Mumbai, Maharashtra, India
Responsibilities
- 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 licenses, test licenses, 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.
Requirements
- 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.
If you are looking for a challenging and rewarding Regulatory Affairs Job with a globally recognized organization, this opportunity through Merck Careers is worth exploring. With exposure to regulatory compliance, product registration, healthcare innovation, and global regulatory practices, the role offers exceptional professional development. Candidates interested in Chemistry Jobs, Life Science Jobs, and Biotechnology Jobs can leverage this position to build a successful career in the pharmaceutical and regulatory affairs industry.
