Global science leader Merck has opened applications for the role of Specialist – Regulatory Affairs in Mumbai. This opportunity is ideal for professionals with a strong background in pharmaceutical regulations, compliance, and product registration.
If you have experience working with CDSCO guidelines, regulatory submissions, and licensing activities, this role offers a chance to work in a globally recognized organization with exposure to international regulatory frameworks.
Job Overview
- Position: Specialist – Regulatory Affairs
- Company: Merck
- Location: Mumbai, Maharashtra
- Job Type: Full-Time
- Job ID: 299425
- Mode: Online Application
Key Responsibilities
- Monitor regulatory updates and policy changes from Indian authorities
- Assess regulatory impact on products and business compliance
- Coordinate with agencies like CDSCO, IPC, DBT, BIS, DAHD, and others
- Prepare and submit regulatory documents (licenses, NOCs, compliance reports)
- Support product registrations for APIs, excipients, and biologicals
- Assist in new product approvals and regulatory pathways
- Ensure compliance with WHO-GMP, GLP, Schedule M standards
- Develop SOPs and maintain regulatory documentation
- Collaborate with internal teams and global stakeholders
Required Qualifications
- Master’s degree in:
- Pharmacy (M.Pharm)
- Life Sciences
- Biotechnology
- Chemistry
- Or related field
- Strong knowledge of:
- CDSCO regulations
- USFDA, EMA guidelines
- Pharmaceutical compliance & audits
- Regulatory submissions & licensing
- Skills:
- Documentation & communication
- Regulatory strategy understanding
- Cross-functional teamwork
Preferred Skills
- Regulatory Affairs expertise
- Product registration & lifecycle management
- Import/export regulatory handling
- Audit readiness & compliance
- SOP development
- Stakeholder coordination
Why Choose Merck?
- Work with a global science & technology leader
- Exposure to international regulatory environments
- Strong career growth opportunities
- Inclusive and innovative work culture
- Learning and development support
Who Should Apply?
This role is perfect for:
- M.Pharm graduates
- MSc Life Sciences / Chemistry professionals
- Biotechnology candidates
- Regulatory Affairs professionals
- Pharma compliance specialists
- Product registration executives
How to Apply
Interested candidates can apply online through the official Merck careers portal:
👉 Visit: Merck Careers Website
(Search using Job ID: 299425)
Frequently Asked Questions (FAQs)
1. What is the job location for this Merck role?
The position is based in Mumbai, Maharashtra.
2. What qualification is required?
A Master’s degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, or related field.
3. Is experience required?
Yes, candidates should have experience in regulatory affairs, compliance, or submissions.
4. What regulatory knowledge is important?
Knowledge of CDSCO, USFDA, EMA, and other global regulatory frameworks is important.
5. Is this a remote job?
No, this is a full-time on-site role in Mumbai.
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