Concord Biotech Hiring Regulatory Affairs
- Company Overview
- Job Role & Responsibilities
- Regulatory Affairs Specialist
- Eligibility / Qualifications
- Required Education
- Relevant Courses
- Experience
- Skills Required
- Location & Salary
- Job Location
- Salary
- Application Process
- Why You Should Apply
- FAQs
- What qualification is required for this role?
- How much experience is needed?
- What type of work will be involved?
- Is this role suitable for freshers?
- What is the application process?
- Summary Table
Concord Biotech Hiring Regulatory Affairs Specialist | Senior Pharma Jobs 2026
Concord Biotech Limited is actively hiring experienced professionals for the Regulatory Affairs Specialist role, offering a strong career opportunity for candidates with 8 to 10 years of experience in pharmaceutical regulatory submissions and compliance. This position is ideal for professionals with a B.Pharm or M.Pharm background who are looking to advance in global regulatory affairs, dossier submission, and pharmaceutical compliance roles.
The company is offering a senior-level opportunity in the Regulatory Affairs department, where candidates will work closely with cross-functional teams and contribute to international market submissions, regulatory approvals, and lifecycle management. This role is suited for professionals aiming to build expertise in regulatory strategy, documentation, and global pharma compliance systems.
Company Overview
Concord Biotech Limited is a well-established pharmaceutical and biotechnology company known for its strong presence in fermentation-based APIs and finished dosage forms. The company has built a solid reputation for quality manufacturing, regulatory excellence, and global market reach.
With operations spanning multiple international markets, Concord Biotech plays a significant role in delivering high-quality pharmaceutical products that meet stringent regulatory standards such as WHO-GMP and CDSCO guidelines. Working here offers exposure to global regulatory frameworks and a chance to contribute to healthcare innovation and drug accessibility.
Job Role & Responsibilities
Regulatory Affairs Specialist
- Prepare, review, and submit regulatory dossiers for product registrations
- Handle manufacturing license applications such as Form 25 and Form 28
- Manage certification processes including WHO-GMP, COPP, FSC, and State GMP
- Review and submit regulatory documents for ROW (Rest of World) markets
- Oversee lifecycle management including variations, renewals, and archival submissions
- Ensure compliance with regulatory authorities like CDSCO, FDCA, and international agencies
- Coordinate with F&D, Quality Control, Production, and Quality Assurance teams
- Perform technical review of BMR, BPR, specifications, change controls, and packaging artworks
Eligibility / Qualifications
Required Education
B.Pharm, M.Pharm
Relevant Courses
Regulatory Affairs, Pharmaceutical Quality Assurance, Drug Regulatory Affairs, Pharmaceutical Analysis, Industrial Pharmacy, Clinical Research, Pharmacovigilance
Experience
- 8 to 10 years of experience in Regulatory Affairs
Skills Required
- Strong knowledge of global regulatory guidelines and submission processes
- Experience with dossier preparation and lifecycle management
- Understanding of GMP, documentation, and compliance systems
- Ability to work with cross-functional pharma teams
Location & Salary
Job Location
- Not explicitly mentioned (Corporate/Manufacturing site based)
Salary
- Competitive salary package aligned with industry standards for senior regulatory roles
Application Process
Interested candidates can apply by sending their updated resume to the official email ID:
Make sure to mention the position “Regulatory Affairs Specialist” clearly in the subject line while applying.
Why You Should Apply
- Senior-level opportunity in a reputed pharmaceutical company
- Exposure to global regulatory markets and submissions
- Work with cross-functional teams in a high-impact role
- Strong career growth in regulatory affairs and compliance
FAQs
What qualification is required for this role?
Candidates must have a B.Pharm or M.Pharm degree.
How much experience is needed?
A minimum of 8 to 10 years of experience in Regulatory Affairs is required.
What type of work will be involved?
The role involves regulatory submissions, compliance management, certification handling, and coordination with internal departments.
Is this role suitable for freshers?
No, this is a senior-level position requiring significant experience.
What is the application process?
Candidates need to send their CV via email with the position mentioned in the subject line.
Summary Table
| Company | Concord Biotech Limited |
|---|---|
| Vacancies | Regulatory Affairs Specialist |
| Required Education | B.Pharm, M.Pharm |
| Experience | 8–10 Years |
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