Senior Director of Regulatory Affairs

1 day ago


Chicago, Illinois, United States Meitheal Pharmaceuticals Inc Full time
Job Title: Senior Director of Regulatory Affairs

Meitheal Pharmaceuticals Inc is seeking a highly skilled Senior Director of Regulatory Affairs to join our team. As a key member of our regulatory affairs department, you will be responsible for providing regulatory guidance and support for the development and commercialization of our generic injectables, biologics, and biosimilars.

Key Responsibilities:
  • Develop and implement regulatory strategies for product development and tech transfer, including biosimilars.
  • Prepare and review submissions, including BIA, BPD, INDs, BLAs, etc.
  • Represent the regulatory function on cross-functional developmental teams and collaborate with Operations, Quality, Legal, and Marketing groups.
  • Lead preparation and management of meetings with health authorities, such as US FDA, EMA.
  • Provide training on CMC and regulatory sciences for biologics and biosimilars within the RA department and cross-functions.
Requirements:
  • Bachelor's, Master's, or Ph.D. degree in life sciences.
  • Over 8 years of related experience in product development and/or regulatory CMC, with a minimum of 3 years in biologics and/or biosimilars.
  • Expertise in and experience with Regulatory Affairs of biosimilars are highly preferred.
What We Offer:
  • A dynamic and growing company with a strong commitment to accessibility and affordability.
  • A collaborative and innovative work environment.
  • Opportunities for professional growth and development.


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