🔬 Regulatory Affairs Jobs 2026 @ Concord Biotech | Pharma Careers Apply

Concord Biotech Careers: Hiring Regulatory Affairs Specialist

Concord Biotech Limited is looking for a dedicated and experienced professional to join our Regulatory Affairs team. This is a senior-level opportunity for experts in the pharmaceutical regulatory landscape to manage critical compliance and submission processes.

Department: Regulatory Affairs

Designation: Regulatory Affairs Specialist

Experience: 8 to 10 Years

Qualification: B. Pharm / M. Pharm

Key Skill or Job Description:

Submissions: Prepare, review, and submit product registration documents and manufacturing licenses (Form 25, 28).
Certifications: Handle applications for WHO-GMP, State GMP, COPP, and FSC certificates.
Emerging Markets: Review regulatory applications for ROW (Rest of World) markets.
Compliance: Manage life cycle applications and archival for FDCA, CDSCO, and Emerging Markets.
Cross-functional Coordination: Liaise with F&D, QC, Production, and QA for submissions.
Technical Review: Audit BMR, BPR, Specs, MOA, Change Controls, Leaflets, PIF, and Artworks.

Who Can Apply

Pharmacy graduates and post-graduates (B.Pharm/M.Pharm) with significant industry experience.
Professionals with a deep understanding of CDSCO, FDCA, and WHO-GMP standards.
Candidates with 8-10 years of proven expertise in Regulatory Affairs.

Why Concord Biotech is a Top Choice for Pharma Professionals

Concord Biotech Limited is a globally recognized R&D-based biopharmaceutical company. Joining Concord means working with a leader in fermentation-based niche biopharmaceuticals. They offer a high-growth environment where regulatory experts handle diverse international markets, providing a platform to master complex global compliance standards.

How To Apply

Interested candidates, please share CV on trushitacharya@concordbiotech.com with clearly mentioned position applied for in the subject line.

Frequently Asked Questions (FAQ)

1) What is the required experience for the Regulatory Affairs Specialist role?

The company requires a minimum of 8 to 10 years of experience in the Regulatory Affairs department.

2) Which qualifications are accepted for this position?

Candidates must hold either a Bachelor of Pharmacy (B. Pharm) or a Master of Pharmacy (M. Pharm) degree.

3) Does this role involve international market regulations?

Yes, the job description specifically mentions reviewing regulatory applications for ROW (Rest of World) markets and Emerging Markets.

4) What are the core technical responsibilities for this role?

Key responsibilities include handling product registration, manufacturing licenses (Form 25, 28), and auditing technical documents like BMR, BPR, and PIF.

5) How should I mention the position when applying via email?

You must clearly mention “Regulatory Affairs Specialist” in the subject line of your email when sending your CV.

Concord Biotech Regulatory Affairs Specialist Job Opening

Concord Biotech Job Vacancy for Regulatory Affairs Specialist.

📋 Concord Biotech – Regulatory Affairs Specialist | 8-10 Years Experience | B.Pharm/M.Pharm | Apply via Email

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