Global science and technology leader Merck has announced an exciting opportunity for experienced regulatory professionals through its latest Specialist – Regulatory Affairs job opening in Mumbai, Maharashtra. This position is ideal for candidates with qualifications in M.Pharm, Life Sciences, Biotechnology, Chemistry, or related disciplines who are looking to build a rewarding career in pharmaceutical regulatory affairs.
The Regulatory Affairs Specialist will play a critical role in ensuring regulatory compliance, supporting product registrations, facilitating import and licensing activities, and engaging with Indian regulatory authorities. Candidates with expertise in CDSCO regulations, pharmaceutical compliance, regulatory submissions, and product lifecycle management are encouraged to apply.
Job Details
Position: Specialist – Regulatory Affairs
Company: Merck
Job Location: Mumbai, Maharashtra, India
Job Type: Full-Time
Job ID: 299425
Key Responsibilities
As a Regulatory Affairs Specialist at Merck, you will:
- Monitor and evaluate regulatory notifications, guidelines, and policy updates issued by Indian regulatory authorities.
- Assess regulatory changes and determine their impact on business operations and product compliance.
- Build and maintain professional relationships with regulatory agencies including CDSCO, IPC, DBT, DAHD, BIS, AQCS, DCPC, and relevant government ministries.
- Support regulatory advocacy initiatives through participation in industry associations and regulatory forums.
- Prepare and submit regulatory applications, including import licenses, test licenses, NOCs, compliance documentation, and audit-related submissions.
- Assist in product registration activities for APIs, excipients, chemicals, biological products, and animal-origin products.
- Support new product launches by identifying appropriate regulatory classifications and approval pathways.
- Coordinate with internal stakeholders to gather documents required for regulatory submissions and authority responses.
- Ensure compliance with WHO-GMP, GLP, Schedule M, and other applicable regulatory standards.
- Develop and maintain Standard Operating Procedures (SOPs) for regulatory operations.
- Provide technical and regulatory support to customers and internal business teams.
- Represent Indian regulatory requirements during global regulatory meetings and cross-functional discussions.
Required Qualifications
Candidates applying for this Regulatory Affairs job should possess:
- Master’s Degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or a related discipline.
- Strong knowledge of Indian and international regulatory frameworks.
- Understanding of CDSCO, IPC, DBT, DAHD, USFDA, EMA, IPEC, PDA, and related regulatory bodies.
- Experience in regulatory submissions, compliance documentation, audits, import licensing, and product registration.
- Knowledge of pharmaceutical and biopharmaceutical manufacturing processes.
- Familiarity with regulatory pathways for APIs, excipients, chemicals, and biological products.
- Excellent communication, documentation, and stakeholder management skills.
- Ability to work effectively within cross-functional teams.
- Willingness to travel domestically when required.
Preferred Skills
- Regulatory Compliance Management
- Pharmaceutical Regulatory Affairs
- Product Registration & Licensing
- Import Regulatory Documentation
- Government Authority Coordination
- Audit Readiness & Compliance
- SOP Development
- Regulatory Advocacy
- Pharma Manufacturing Compliance
- Cross-Functional Collaboration
Why Join Merck?
Merck is recognized globally for its commitment to innovation in Healthcare, Life Science, and Electronics. Employees benefit from:
- Exposure to global regulatory environments.
- Opportunities to work with international teams.
- Career growth within a world-leading science and technology organization.
- Inclusive and diverse workplace culture.
- Learning and development opportunities.
- Participation in impactful healthcare and life science innovations.
Who Should Apply?
This opportunity is highly suitable for:
- M.Pharm graduates and postgraduates
- MSc Life Sciences professionals
- Biotechnology professionals
- Chemistry postgraduates
- Regulatory Affairs Specialists
- Pharmaceutical Compliance Professionals
- Product Registration Executives
- Regulatory Submission Associates
How to Apply
