Concord Biotech Limited has announced an exciting hiring opportunity for experienced professionals in the field of Regulatory Affairs. This senior-level position is ideal for candidates with 8 to 10 years of experience who are looking to advance their career in pharmaceutical regulatory submissions, compliance, and global market exposure.
If you have a background in B.Pharm or M.Pharm and strong expertise in dossier preparation, certifications, and regulatory coordination, this role offers excellent growth and exposure to international regulatory standards.
About Concord Biotech Limited
Concord Biotech Limited is a well-established pharmaceutical and biotechnology company known for its expertise in fermentation-based APIs and finished dosage forms. The company has a strong global presence and adheres to international quality standards such as WHO-GMP and CDSCO.
Working at Concord Biotech provides an opportunity to engage in global regulatory practices and contribute to high-quality healthcare solutions.
Job Role: Regulatory Affairs Specialist
This role involves handling regulatory submissions, compliance management, and coordination with multiple departments to ensure smooth approval processes across global markets.
Key Responsibilities
- Prepare, review, and submit regulatory dossiers for product registrations
- Handle manufacturing license applications (Form 25 & 28)
- Manage certifications such as WHO-GMP, COPP, FSC, and State GMP
- Review and submit regulatory applications for ROW (Rest of World) markets
- Oversee lifecycle management including variations, renewals, and archival
- Ensure compliance with CDSCO, FDCA, and international regulatory bodies
- Coordinate with F&D, QC, Production, and QA teams
- Perform technical review of BMR, BPR, specifications, change controls, and artworks
Eligibility Criteria
Educational Qualification
- B.Pharm
- M.Pharm
Experience
- 8 to 10 years in Regulatory Affairs
Required Skills
- Strong knowledge of global regulatory guidelines
- Expertise in dossier preparation and submissions
- Understanding of GMP and compliance systems
- Ability to work with cross-functional teams
Salary & Benefits
- Estimated Salary Range: โน8 LPA โ โน14 LPA (based on experience)
- Opportunity to work on global regulatory projects
- Career growth in a reputed pharmaceutical company
- Exposure to international compliance standards
Job Location
- India (Exact location not specified โ corporate/manufacturing site based)
How to Apply
Interested candidates can apply by sending their updated CV to:
trushitacharya@concordbiotech.com
Make sure to mention โRegulatory Affairs Specialistโ in the subject line of your email.
