Regulatory Affairs Professional

19 hours ago

Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 15,00,000 - ₹ 20,00,000
About This Role

This Regulatory Affairs position is focused on the development and execution of regulatory strategies for complex products.

The incumbent will be responsible for ensuring compliance with regulatory requirements across multiple markets, including the US, Europe, and UK.

Specifically, this role involves:

  • Regulatory Compliance: Ensuring adherence to FDA and EMA guidelines for IND/NDA submissions, CTD dossier preparation, and post-approval variations.
  • Study Requirements: Defining nonclinical and clinical study needs for 505(b)(2) products, including bridging studies and formulation complexities.
  • CMC Documentation: Preparing and reviewing CMC documents, including eCTD submissions and CMC document review.

Key skills required for this position include expertise in 505(b)(2), IND/NDA/Hybrid Applications, and CMC compliance. The ideal candidate will also have strong knowledge of EMA/FDA guidelines, clinical trial regulations, and GMP standards.

Qualifications
  • Minimum 10+ years' experience in the pharmaceutical industry with a focus on regulatory affairs.
  • Proven track record of success in handling regulatory compliance across multiple markets.
  • Strong understanding of regulatory guidelines, including FDA and EMA regulations.
  • Excellent communication and project management skills.

Certifications in Regulatory Compliance or Drug Development Clinical Studies are desirable but not essential.

Benefits

As a member of our team, you can expect a competitive remuneration package that reflects your professional experience and qualifications.

Additionally, you will have the opportunity to work on complex projects, develop your skills, and contribute to the growth and success of our organization.

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