Biotechnology Job at Merck | Candidates Apply Now
Are you looking for a Biotechnology Job in the regulatory affairs domain with a globally renowned science and technology company? Merck Careers has announced an exciting opportunity for the Specialist – Regulatory Affairs position in Mumbai, Maharashtra. This Regulatory Affairs Job is ideal for candidates with expertise in biotechnology, life sciences, pharmacy, chemistry, and regulatory compliance seeking to build a rewarding career in the pharmaceutical and biopharmaceutical industry.
About Merck
Merck is a leading global science and technology company focused on Healthcare, Life Science, and Electronics. With a strong presence across multiple countries, Merck develops innovative solutions that help improve human health, advance scientific research, and drive technological progress. The company is recognized for its commitment to innovation, sustainability, and empowering professionals to create meaningful impact through science and technology.
Job Details
| Position | Specialist – Regulatory Affairs |
| Job ID | 299425 |
| Company | Merck |
| Location | Mumbai, Maharashtra, India |
| Job Type | Full-Time |
Key Responsibilities
- 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 (SOPs) for the regulatory function.
- Provide technical and regulatory support to customers and internal stakeholders.
- Represent India’s regulatory interests in global regulatory meetings and provide insights on Indian regulatory requirements.
Qualifications
- 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 Required
- 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, animal by-products, biological origin products, and related categories.
- Experience engaging with regulatory authorities, government bodies, or industry associations is preferred.
Skills Needed
- 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.
- Regulatory compliance and documentation management.
- Stakeholder engagement and regulatory advocacy.
- Product registration and import compliance expertise.
If you are seeking a challenging Regulatory Affairs Job in the pharmaceutical and biotechnology sector, this opportunity through Merck Careers is an excellent choice. Candidates with expertise in regulatory compliance, product registration, and biotechnology can leverage this Biotechnology Job to build a successful career while contributing to global regulatory excellence and innovation.
