Regulatory Affairs Specialist
5 hours ago
🚀 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 productsSupport regulatory strategy and documentation for clinical and commercial CGT programsCoordinate with CMC, Manufacturing, Quality, and Analytical teamsEnsure compliance with FDA, EMA, ICH, and other global regulatory guidelinesManage regulatory queries, variations, amendments, and responsesMaintain regulatory documentation and lifecycle management activitiesRequired Skills & Experience:Hands-on experience in Regulatory Affairs – CMCStrong understanding of Cell Therapy / Gene Therapy / ATMPsKnowledge of manufacturing processes, characterization, comparability, and control strategiesExperience with CMC documentation for IND/CTA/BLA submissionsFamiliarity with ICH guidelines (Q-series), FDA, EMA regulationsExcellent communication and cross-functional collaboration skillsPreferred Qualifications:Degree in Pharmacy, Biotechnology, Life Sciences, or related fieldExperience working on CGT products.Exposure to global regulatory submissions is a plus✨ Why Join Us?Work on cutting-edge Cell & Gene Therapy programsCollaborative and growth-oriented environmentOpportunity to build deep expertise in CGT Regulatory CMC📩 Interested candidates: Please share your resume on below mentioned mail id or connect via with a brief summary of your CMC experience in Cell & Gene Therapy.Mail ID :- satyaprakash.sharma@microcrispr.com
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Regulatory Affairs Specialist
6 hours ago
Vapi, India Meril Full time🚀 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) 📍...
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Regulatory Affairs Specialist
3 hours ago
vapi, India Meril Full time🚀 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) 📍...
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Regulatory Affairs Specialist
3 hours ago
Vapi, India Meril Full time🚀 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)...
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Regulatory Affairs Executive
4 weeks ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeKey Responsibilities:1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...
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Regulatory affairs executive
4 weeks ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeKey Responsibilities:1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory...
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Regulatory Affairs Executive
5 days ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeKey Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory...
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Regulatory Affairs Executive
4 days ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeKey Responsibilities: 1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). 2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets). 3. Prepare, review, and manage high-quality regulatory...
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Manager Global Regulatory Affairs
2 days ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeWe are seeking an experienced Regulatory Affairs professional to lead and execute global regulatory strategies for biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals across US,...
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Manager Global Regulatory Affairs
2 days ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeWe are seeking an experienced Regulatory Affairs professional to lead and execute global regulatory strategies for biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals across US,...
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Manager Global Regulatory Affairs
2 days ago
Vapi, India Micro Crispr Pvt. Ltd. Full timeWe are seeking an experienced Regulatory Affairs professional to lead and execute global regulatory strategies for biologic products across multiple development stages. The role involves close collaboration with cross-functional teams and direct engagement with global regulatory authorities to support successful product development and approvals across US,...
