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Regulatory Affairs Director

2 months ago

Uxbridge, United Kingdom Gilead Sciences International, Ltd. Full time
Job Description

Job Title: Director, Global Regulatory Affairs Liaison

Job Summary:

We are seeking a highly experienced and skilled Director, Global Regulatory Affairs Liaison to join our team at Gilead Sciences International, Ltd. The successful candidate will be responsible for leading the development and implementation of regulatory strategies for our global products, ensuring compliance with regulatory requirements and maintaining strong relationships with regulatory authorities.

Key Responsibilities:

  • Develop and implement regulatory strategies for global products, ensuring compliance with regulatory requirements
  • Lead cross-functional teams to prepare and submit regulatory documents, including INDs, NDAs, and MAAs
  • Represent Gilead in negotiations with regulatory authorities, ensuring effective communication and resolution of issues
  • Provide strategic advice and guidance to regulatory teams, ensuring alignment with business objectives
  • Manage and maintain relationships with regulatory authorities, ensuring timely and effective communication
  • Develop and implement processes and procedures to ensure compliance with regulatory requirements
  • Collaborate with cross-functional teams to ensure regulatory requirements are integrated into product development and commercialization
  • Stay up-to-date with regulatory developments and changes, ensuring Gilead remains compliant and competitive

Requirements:

  • BA/BS or advanced degree in life sciences or related field
  • Extensive experience in regulatory affairs, including experience working with regulatory authorities
  • Proven track record of developing and implementing successful regulatory strategies
  • Strong leadership and communication skills, with ability to influence and motivate cross-functional teams
  • Ability to work in a fast-paced environment, with multiple priorities and deadlines
  • Strong analytical and problem-solving skills, with ability to think critically and strategically

What We Offer:

Gilead Sciences International, Ltd. offers a competitive salary and benefits package, as well as opportunities for professional growth and development. We are an equal opportunities employer and welcome applications from diverse candidates.