About the Company
Zydus Lifesciences Limited is a leading global pharmaceutical company headquartered in Ahmedabad, India. With a strong legacy of innovation, the company develops and commercializes a wide range of products including generics, biosimilars, vaccines, and novel therapies.
Zydus maintains stringent regulatory compliance across multiple markets and operates state-of-the-art manufacturing and research facilities. Committed to quality healthcare, the organization continues its robust growth while serving patients in over 50 countries worldwide.
Job Details
- Company Name: Zydus Lifesciences Limited
- Experience: 8 years and above
- Qualification: M.Sc / B.Tech / B.Pharm / M.Pharm / M.Tech / Ph.D in Biotechnology, Microbiology or related fields
- Location: Ahmedabad
- Work Type: On-site
Job Description
Zydus Research Centre is expanding its Regulatory Affairs team in the Biotech division. The company is seeking seasoned professionals to handle complex regulatory strategies, dossier preparations, and post-approval activities for biotechnology products. These roles are vital for ensuring timely market approvals and maintaining compliance in global and domestic markets.
Associate Manager / Manager / Sr. Manager – Biotech Regulatory Affairs
- Department: Regulatory Affairs (Biotech)
- Market: Pharmaceuticals & Biotechnology
- Role: Regulatory Affairs Manager
- Experience: 8 years and above
- Education/Qualification: M.Sc / B.Tech / B.Pharm / M.Pharm / M.Tech / Ph.D in Biotechnology, Microbiology
Skills/Qualifications
- In-depth knowledge of CTD, ACTD, eCTD dossier formats and global regulatory requirements
- Strong understanding of biotechnology and pharmaceutical regulations
- Excellent coordination and communication skills with cross-functional teams
- Proficiency in gap analysis, document review, and query management
- Ability to monitor regulatory updates and perform impact assessments
- Experience in managing relationships with regulatory authorities
Key Responsibilities
- Prepare and submit regulatory dossiers for global markets
- Manage master dossier updates and query responses
- Coordinate with cross-functional teams for registrations
- Support post-approval changes and commercialization
- Conduct gap analysis and artwork management
- Ensure ongoing compliance with regulatory guidelines
Benefits/Perks
- Competitive compensation and performance incentives
- Career growth in global regulatory affairs
- Opportunities for learning advanced biotech regulations
- Collaborative and innovative work culture
- Exposure to international pharmaceutical markets
How to Apply
Interested candidates can scan the QR code or apply through the official Zydus career portal. For more pharma jobs and pharmaceutical careers in India, visit .
Join Zydus and contribute to life-changing therapies—apply now!
Walk-in Interview Details
No specific walk-in details provided. Apply via official channels.
Why You Should Join
Zydus Lifesciences nurtures a culture of innovation, recognition, and excellence in regulatory practices. Professionals enjoy long-term career stability, continuous learning in cutting-edge biotechnology, and a compliant environment that values quality and global impact. Be part of a forward-thinking team dedicated to advancing healthcare solutions worldwide.
FAQs
Q1: What experience is needed for Regulatory Affairs roles at Zydus Lifesciences?
Q2: Which qualifications are preferred for these positions?
Q3: Where is the Zydus Research Centre located?
Q4: What growth opportunities exist in this role?
