Director of Regulatory Affairs

2 months ago

Marlborough, United States Hobson Prior Full time

Hobson Prior is seeking a Director of Regulatory Affairs to join a leading biotechnology company. This position, based in the US (remote), will require working with a team located mainly in Europe and will therefore require both flexibility and the ability to work in an international environment. This role focuses on supporting new drug applications and ensuring compliance with regulatory requirements. You will be the main contact for the FDA and contribute to the development of regulatory strategies.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

  • Help prepare and submit new drug applications in the US.
  • Ensure compliance with local regulatory requirements once the product is approved.
  • Act as the main contact for the FDA.
  • Develop and propose regulatory plans and strategies.
  • Coordinate and oversee all submissions to the FDA for assigned projects.
  • Provide strategic support for various compounds and potential extensions.

Key Skills & Requirements:

  • Advanced degree in natural sciences.
  • Extensive experience in regulatory affairs within the pharmaceutical or biotech industry.
  • Skilled in preparing and submitting regulatory documents.
  • Understanding of regulatory submission processes.
  • Familiarity with post-marketing requirements is a plus.

For more information, please contact Henry LeLacheur at

Apply now

If you are interested in learning more or applying to this exciting opportunity then please click 'Apply' and upload a copy of your CV. Alternatively for further details or to talk directly to a life sciences recruitment specialist directly please select 'Contact me' at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

By providing your details and submitting this form you confirm you have read and understood our privacy policy. We only share your personal details with our group companies at acaciumgroup.com/affiliates and those categories of third parties in our privacy policy at hobsonprior.com/privacy-policy.

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