Specialist – Regulatory Affairs

The Regulatory Affairs Specialist will play a critical role in ensuring regulatory compliance, supporting product registrations, facilitating import and licensing activities, engaging with Indian regulatory authorities, and contributing to successful product lifecycle management.

The role requires close collaboration with regulatory agencies, internal stakeholders, industry associations, and global teams while ensuring compliance with Indian and international regulatory standards.

🚀 WE’RE HIRING | Specialist – Regulatory Affairs | Merck | Mumbai 🚀

Are you passionate about Regulatory Affairs, Pharmaceutical Compliance, Product Registration, and Global Regulatory Strategy? 📋💊🌍

📢 Merck is hiring a Specialist – Regulatory Affairs in Mumbai for professionals looking to build a rewarding career in pharmaceutical regulatory affairs, compliance management, and regulatory operations.

This is an excellent opportunity for candidates with expertise in CDSCO regulations, regulatory submissions, import licensing, product registration, compliance documentation, and pharmaceutical regulatory affairs to work with one of the world’s leading science and technology organizations.

If you are looking to contribute to global healthcare innovation while working with regulatory authorities and international teams, this opportunity could be the ideal next step in your career.

🏢 Company: Merck
🌐 Website: https://www.merckgroup.com
👉 Role: Specialist – Regulatory Affairs
💼 Job ID: 299425
📍 Location: Mumbai, Maharashtra, India
🏢 Work Mode: On-site
🕒 Employment Type: Full-Time

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🔧 Key Responsibilities
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✔ 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

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🛠 Required Qualifications
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🎓 Educational Qualification
✅ Master’s Degree in Pharmacy
✅ Life Sciences
✅ Biotechnology
✅ Chemistry
✅ Related Scientific Disciplines

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🎯 Required Knowledge & Expertise
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✅ 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

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✨ Why Join Merck?
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✨ 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
✨ Opportunity to Influence Regulatory Strategy and Product Compliance
✨ Strong Professional Growth and Leadership Development Opportunities

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🎯 Who Should Apply?
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✅ 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

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🏢 About Merck
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Merck is a global science and technology leader operating across Healthcare, Life Science, and Electronics sectors. The company is dedicated to solving some of the world’s toughest challenges through scientific innovation, advanced technologies, and sustainable solutions.

With a strong global presence and commitment to research, quality, and compliance, Merck continues to empower healthcare professionals, researchers, and industries worldwide.

🚀 Core Focus Areas:
✅ Healthcare Innovation
✅ Life Science Solutions
✅ Pharmaceutical Regulatory Excellence
✅ Biotechnology & Advanced Research
✅ Global Compliance & Quality Systems
✅ Scientific Innovation
✅ Sustainable Technology Solutions

Interested and eligible candidates can apply through the official Merck careers portal.

🔁 Referrals are highly appreciated!

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⚡ If you’re looking to build a successful career in Regulatory Affairs, Compliance Management, Product Registration, and Global Pharmaceutical Operations, Merck offers an outstanding opportunity to work on impactful regulatory initiatives while growing with a world-renowned science and technology organization.