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Medopharm, a leading pharmaceutical company specializing in generics and contract manufacturing, is hiring for Regulatory Affairs professionals to join its dynamic team in Chennai, India.
With a strong global presence in over 25 countries and a commitment to quality, Medopharm invites experienced candidates to contribute to its mission of delivering affordable, high-quality medicines. This is your chance to excel in a role focused on bioequivalence (BE) support, WHO Prequalification (PQ), and European market compliance.
Application Details
We are seeking candidates with expertise in regulatory affairs for our Chennai office. To apply, email your resume to hr@medopharm.com. The work location is Medopharm, 25, Puliyur 2nd Main Road, Kodambakkam, Chennai – 600024, Tamil Nadu. For more details, visit Medopharm Careers.
Why Choose Medopharm?
Established in 1971, Medopharm is a trusted name in the pharmaceutical industry, exporting to over 25 countries with WHO-GMP and EU-GMP certified facilities. With a focus on generics, APIs, and contract manufacturing, Medopharm offers a collaborative environment for professionals to drive regulatory excellence and support global market access.
Join a team dedicated to innovation and quality healthcare solutions.
Position and Qualifications
We are hiring for roles in the Regulatory Affairs department with the following requirements:
| Position | Qualification | Experience | Key Responsibilities |
|---|---|---|---|
| Regulatory Affairs Professional | B.Pharm / M.Pharm / M.Sc (preferred) | 5+ years | Support bioequivalence studies, WHO PQ, dossier preparation, query handling, European market compliance |
Key Responsibilities
- Support bioequivalence (BE) studies for regulated markets, ensuring compliance with global standards.
- Prepare and manage dossiers in CTD/eCTD format for WHO Prequalification (PQ) and European markets.
- Handle regulatory queries and coordinate responses with health authorities (e.g., EMA, WHO).
- Ensure alignment with EU regulatory requirements and ICH guidelines for product registrations.
- Conduct gap analysis and provide strategic regulatory advice for market approvals.
- Collaborate with cross-functional teams (R&D, quality, and manufacturing) to support product lifecycle management.
How to Apply
Email your resume to hr@medopharm.com with the following documents:
- Updated resume
- Copies of educational certificates (B.Pharm/M.Pharm/M.Sc or equivalent)
- Experience letters from previous employers
- Last three months’ salary slips
- Aadhar card copy
- Passport-size photographs
For additional information, visit Medopharm Careers or contact +91 44 2483 3604.
Contact Information
For inquiries, email hr@medopharm.com or call +91 44 2483 3604. Follow Medopharm on LinkedIn for updates. The Chennai office is located at 25, Puliyur 2nd Main Road, Kodambakkam, Chennai – 600024, Tamil Nadu.
Why This Opportunity Matters
As a Regulatory Affairs professional at Medopharm, you’ll play a critical role in ensuring compliance for bioequivalence studies and WHO PQ, while supporting market access in Europe.
With over 5 years of experience, you’ll contribute to dossier preparation and query handling in a company with EU-GMP and WHO-GMP certifications, offering significant career growth in a global pharmaceutical leader.
Preparation Tips for Application
To stand out:
- Tailor Your Resume: Highlight experience in BE studies, WHO PQ, dossier preparation, and European market regulations.
- Research Medopharm: Understand our focus on generics, contract manufacturing, and global compliance.
- Prepare for Technical Discussions: Be ready to discuss CTD/eCTD dossier preparation, query handling, and EU regulatory requirements.
- Submit Complete Documents: Ensure all required documents are included in your email application.
About Medopharm
Medopharm, founded in 1971, is a Chennai-based pharmaceutical company specializing in generics, APIs, and contract manufacturing. With exports to over 25 countries and certifications like WHO-GMP and EU-GMP, Medopharm is a trusted partner for global pharmaceutical needs. Its state-of-the-art facilities and R&D focus drive innovation in affordable healthcare solutions.
Final Call to Action
Join Medopharm and advance your career in regulatory affairs. Apply by emailing your CV to hr@medopharm.com. Visit Medopharm Careers for more details. Be part of a global leader in pharmaceutical excellence!