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Senior Director of Regulatory Affairs

1 month 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 our biopharmaceutical products.

Key Responsibilities:
  • Develop and implement regulatory strategies for biopharmaceutical products
  • Prepare and review regulatory submissions, including BIA, BPD, INDs, BLAs, etc.
  • Collaborate with cross-functional teams to ensure regulatory compliance
  • Represent the company in meetings with health authorities, such as US FDA, EMA
  • Provide training on CMC and regulatory sciences for biologics and biosimilars
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:
  • Opportunity to work with a dynamic and growing company
  • Collaborative and supportive work environment
  • Competitive salary and benefits package