Genedrift is a dynamic and innovative force in the pharmaceutical industry. We are dedicated to pushing the boundaries of science and technology to develop groundbreaking therapies. Our mission is to enhance patient lives by ensuring access to high-quality, advanced medical products, including Biosimilars, Biologicals, Medical Devices, and Injectables.
We are the minds behind Pharmabharat.org, a leading platform committed to empowering the pharmaceutical community in India with the latest news, insights, and career opportunities. When you join Genedrift, you’re not just taking a job; you’re contributing to a larger ecosystem that supports and grows the pharma sector.
Job Description: Senior Executive Regulatory Affairs
We are seeking a highly motivated and experienced Senior Executive for our Regulatory Affairs team. This is a pivotal role where you will be responsible for navigating the complex regulatory landscape to bring our innovative products to market.
Key Responsibilities:
- Prepare, review, and compile regulatory submissions for domestic and international markets (e.g., USFDA, EMA, CDSCO).
- Lead the CMC (Chemistry, Manufacturing, and Controls) review for a diverse portfolio of products.
- Manage end-to-end regulatory strategy for BIOSIMILAR and BIOLOGICAL product applications.
- Handle regulatory documentation for MEDICAL DEVICES and INJECTABLES.
- Ensure all regulatory activities comply with current guidelines and regulations.
- Liaise with cross-functional teams (R&D, Quality, Manufacturing) and health authorities.
- Maintain up-to-date knowledge of changing regulatory policies.
Qualifications & Experience We’re Looking For
The ideal candidate is detail-oriented, proactive, and has a solid foundation in regulatory science.
- A minimum of 2 years of work experience in the Regulatory Affairs field within the pharmaceutical or biotech industry.
- Hands-on experience in the CMC review of the following product categories is essential:
- BIOSIMILAR products
- BIOLOGICAL products
- MEDICAL DEVICES
- INJECTABLES
- Strong understanding of regulatory guidelines (ICH, WHO, GMP).
- Excellent written and verbal communication skills.
- A degree in Pharmacy, Life Sciences, or a related field.
How to Apply
If you are ready to “Invent. Reinvent.” your career with Genedrift, we would love to hear from you.
Please send your updated CV (Curriculum Vitae) to the following email addresses:
Email 1: astha@genedrift.com
Email 2: divya@genedrift.com
