Regulatory Affairs Director

4 weeks ago


Étreux, Hauts-de-France, United States Jacobs Management Group Full time
About the Role

We are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Jacobs Management Group. As Vice President of Regulatory Affairs, you will play a critical role in shaping the regulatory strategy for our pioneering biotech company.

Key Responsibilities
  • Develop and implement regulatory strategies that support our clinical development programs, with a focus on ALS, MS, and Parkinson's therapies.
  • Oversee and manage the preparation, submission, and approval process of regulatory filings, including BLAs, INDs, and other necessary submissions.
  • Ensure that all company activities comply with relevant regulatory requirements and guidelines, including FDA, EMA, and other global regulatory bodies.
  • Collaborate with cross-functional teams on global regulatory submissions and stay abreast of the evolving regulatory landscape.
  • Build and lead a high-performing regulatory affairs team, providing mentorship and fostering a culture of compliance and continuous improvement.
Requirements
  • Expert in global regulatory requirements for neurodegenerative therapies.
  • Proven leader with strong project management and collaboration skills.
  • Excellent communicator, capable of effective interaction with regulatory bodies.
  • Thrive in a fast-paced, dynamic environment with multiple priorities.
How to Apply

We'd love to hear from you if you're interested in this exciting opportunity. Please send an email to [insert email] and tell us why you're the perfect fit for this role.



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