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Merck Hiring Specialist – Regulatory Affairs | Regulatory Compliance & Product Registration
🏢 Merck
📍 Mumbai
📄 Specialist – Regulatory Affairs
💼 Full-Time
Merck has announced an exciting opportunity for Regulatory Affairs professionals in Mumbai. This role is ideal for candidates with backgrounds in Pharmacy, Life Sciences, Biotechnology, Chemistry, and Regulatory Affairs who are interested in product registrations, compliance management, licensing, and regulatory submissions.
The position offers exposure to Indian and international regulatory frameworks while supporting healthcare, life science, and pharmaceutical business operations.
📋 Job Overview
| Details | Information |
|---|---|
| Position | Specialist – Regulatory Affairs |
| Company | Merck |
| Location | Mumbai, Maharashtra |
| Job Type | Full-Time |
| Job ID | 299425 |
| Industry | Pharmaceutical / Life Sciences |
| Qualification | M.Pharm, Life Sciences, Biotechnology, Chemistry or Related Discipline |
💰 Expected Salary Range: ₹8 LPA – ₹15 LPA
🏢 About Merck
Merck is a global science and technology leader operating across Healthcare, Life Science, and Electronics sectors. The company is known for innovation, scientific excellence, and a strong commitment to improving lives through cutting-edge technologies and healthcare solutions.
📌 Key Responsibilities
- Monitor regulatory notifications, policies, and compliance updates.
- Evaluate the impact of regulatory changes on business operations.
- Coordinate with CDSCO, IPC, DBT, DAHD, BIS, AQCS, and government authorities.
- Prepare and submit import licenses, NOCs, test licenses, and regulatory applications.
- Support product registration activities for APIs, excipients, chemicals, and biological products.
- Assist in regulatory approval pathways for new product launches.
- Coordinate documentation and authority responses.
- Ensure compliance with WHO-GMP, GLP, Schedule M, and other regulations.
- Develop and maintain SOPs for regulatory operations.
- Provide technical and regulatory support to business teams and customers.
- Represent Indian regulatory requirements during global discussions.
📚 Regulatory Affairs Resources
👉 Career Opportunities After Pharmacy
👉 Pharma Career & Salary Guide
👉 Browse Pharma Knowledge Articles
🎓 Eligibility Criteria
- Master of Pharmacy (M.Pharm)
- Life Sciences
- Biotechnology
- Chemistry
- Related Scientific Discipline
Required Knowledge:
- CDSCO Regulations
- USFDA & EMA Frameworks
- Regulatory Submissions
- Import Licensing
- Product Registration
- Compliance Documentation
- Audit Support Activities
💡 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
- Stakeholder Management
- Regulatory Intelligence
🎁 Why Join Merck?
- Exposure to global regulatory environments.
- Opportunity 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.
- Strong focus on employee development and collaboration.
👨🔬 Who Should Apply?
- M.Pharm Graduates & Postgraduates
- M.Sc Life Sciences Professionals
- Biotechnology Professionals
- Chemistry Postgraduates
- Regulatory Affairs Specialists
- Pharmaceutical Compliance Professionals
- Product Registration Executives
- Regulatory Submission Associates
📄 Resume & Interview Preparation Tips
- Highlight Regulatory Affairs, Product Registration, and Licensing experience.
- Mention exposure to CDSCO, USFDA, EMA, or other regulatory authorities.
- Showcase experience in compliance documentation and audit support.
- Include SOP development, regulatory submissions, and lifecycle management activities.
- Use an ATS-friendly and achievement-focused resume format.
🧠 Career Development Resources
👉 Top Pharmacovigilance Interview Questions
👉 Pharmacovigilance Quiz
👉 Browse Healthcare & Pharma Knowledge Articles
📝 How to Apply
- Read the complete job description carefully.
- Prepare an updated ATS-friendly resume.
- Highlight Regulatory Affairs, Compliance, and Product Registration experience.
- Complete the 15-second countdown timer to unlock the application button.
- Apply only if your profile matches the role requirements.
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📌 Note Before You Apply:
Kindly read the entire job description carefully before applying. Make sure your qualifications and experience align with the role requirements. Applying thoughtfully increases your chances of being shortlisted and creates a strong professional impression.
Kindly read the entire job description carefully before applying. Make sure your qualifications and experience align with the role requirements. Applying thoughtfully increases your chances of being shortlisted and creates a strong professional impression.
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