Reliance Life Sciences Careers: Regulatory Affairs Specialist – Biosimilars
Are you ready to take your career in regulatory affairs to the next level? We are looking for a dedicated and experienced professional to join our Biosimilar business team. If you have a passion for regulatory submissions and a keen eye for detail, this could be the perfect opportunity for you!
Job Purpose: Support regulatory submissions in developed and emerging markets for our Biosimilar business.
Accountabilities:
- Reviewing and preparing regulatory filing packages/dossiers for product registrations in the US, EU, and emerging markets.
- Coordinating with concerned groups on regulatory deliverables.
Educational Qualifications:
- Necessary: M. Pharm / M.Sc. in Biotechnology or Life Science.
- Desirable: Diploma in Regulatory Affairs.
Relevant Experience:
- Necessary: 6 to 9 years of regulatory experience, with at least 5 years in handling biological products or biosimilars. Additionally, at least 2 years should be focused on regulatory filings in developed markets, with expertise in technical review and scientific writing of CMC sections.
- Desirable: Experience participating in Scientific advice/BPD/IND meetings with agencies, and prior experience in QA or Process Development functions in Biopharma.
If you are ready to contribute to a dynamic team and make a significant impact in the field of
biosimilars, apply now and take the next step in your professional journey with us!To apply, please send your resume to [email protected]
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