Regulatory Affairs Specialist

We’re Hiring | Regulatory Affairs – CMC (Cell & Gene Therapy)
We are looking for a Regulatory Affairs professional with strong CMC expertise in Cell & Gene Therapy (CGT) to join our growing team.

This role offers an exciting opportunity to work on innovative therapies and global regulatory submissions.

Role:
Regulatory Affairs – CMC (CGT)

Location:

Mumbai (Maharashtra) // Vapi (Gujarat)

Experience:

3–10 years

Key Responsibilities:

Prepare, review, and manage CMC sections for regulatory submissions (IND, CTA, BLA, MAA, etc.) related to Cell & Gene Therapy products
Support regulatory strategy and documentation for clinical and commercial CGT programs
Coordinate with CMC, Manufacturing, Quality, and Analytical teams
Ensure compliance with FDA, EMA, ICH, and other global regulatory guidelines
Manage regulatory queries, variations, amendments, and responses
Maintain regulatory documentation and lifecycle management activities
Required

Skills & Experience:

Hands-on experience in Regulatory Affairs – CMC
Strong understanding of Cell Therapy / Gene Therapy / ATMPs
Knowledge of manufacturing processes, characterization, comparability, and control strategies

Experience with CMC documentation for IND/CTA/BLA submissions
Familiarity with ICH guidelines (Q-series), FDA, EMA regulations
Excellent communication and cross-functional collaboration skills

Preferred Qualifications:

Degree in Pharmacy, Biotechnology, Life Sciences, or related field
Experience working on CGT products.
Exposure to global regulatory submissions is a plus

✨ Why Join Us?
Work on cutting-edge Cell & Gene Therapy programs
Collaborative and growth-oriented environment
Opportunity to build deep expertise in CGT Regulatory CMC

Interested candidates:
Please share your resume on below mentioned mail  connect via Linked In with a brief summary of your CMC experience in Cell & Gene Therapy.

Mail  :

- satyap