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 id or connect via LinkedIn with a brief summary of your CMC experience in Cell & Gene Therapy.

Mail ID :- satyaprakash.sharma@microcrispr.com