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Regulatory Affairs Director

2 months ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences International, Ltd. Full time

Job Summary:

Gilead Sciences International, Ltd. is seeking an experienced Regulatory Affairs professional to join our team as an Associate Director, Regulatory Strategy. This role will be responsible for providing strategic guidance and oversight to our in-market partners in the Gilead Patient Solutions (GPS) region, ensuring compliance with regulatory requirements and aligning with commercial priorities.

Key Responsibilities:

  • Develop and implement regional and national regulatory strategies to ensure compliance with registration requirements and company strategy.
  • Provide regulatory oversight and guidance to in-market partners, ensuring they meet Gilead's high quality and compliance standards.
  • Collaborate with cross-functional teams, including Quality, Patient Safety, Trade Operations & Supply, Legal, Medical Affairs, Finance, and Access, to ensure regulatory alignment with commercial priorities.
  • Manage regulatory capability for Gilead's in-market partners, including due diligence, distributor on-/off-boarding, and periodic regulatory training.
  • Develop and maintain relationships with regulatory agencies and industry associations to stay up-to-date on regulatory trends and requirements.
  • Provide regulatory input to support product launch activities and assess emerging regulatory issues that may impact product supply.
  • Contribute to regional cross-functional meetings and represent Gilead Regulatory in external meetings as required.

Requirements:

  • Experience in regulatory affairs across international markets, including regulatory submission experience and a good understanding of the drug development process.
  • In-depth knowledge of regulatory requirements, including ICH requirements and regional requirements.
  • Knowledge of current global and regional trends in biopharmaceutical regulatory affairs.
  • Experience working with and/or oversight of distributor markets/external vendors is advantageous.
  • Ability to lead cross-functional teams and develop, communicate, and implement regulatory strategy.
  • Excellent verbal and written English communication skills and demonstration of excellent interpersonal and multicultural skills.
  • Excellent planning and organizational skills with the ability to work simultaneously on multiple projects with tight timelines.

Education and Experience:

  • Bachelor's degree in Health or Pharmaceutical Sciences.
  • Significant experience in Regulatory Affairs, including Pharma/Biotech industry and/or partnering with and/or responsible for oversight of in-market partners.
  • Experience in interacting with Regulatory Agencies.
  • Strong background in dossier preparation and regulatory submissions.
  • Ability to read, write, and speak English at an advanced level.

What We Offer:

Gilead Sciences International, Ltd. offers a competitive salary and benefits package, as well as opportunities for professional growth and development in a dynamic and innovative company.