Head of Regulatory Affairs Operations

9 hours ago

Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full time
Job Title: Head of Regulatory Affairs Operations

Job Summary:

We are seeking a highly experienced and skilled Head of Regulatory Affairs Operations to join our team at Gilead Sciences, Inc. The successful candidate will be responsible for leading the development and implementation of global regulatory strategies, processes, and systems to ensure compliance with regulatory requirements and industry standards.

Key Responsibilities:

  • Lead the development and implementation of global regulatory strategies, processes, and systems to ensure compliance with regulatory requirements and industry standards.
  • Collaborate with cross-functional teams to identify and mitigate regulatory risks and ensure compliance with regulatory requirements.
  • Develop and maintain relationships with regulatory authorities and industry stakeholders to stay up-to-date on regulatory developments and trends.
  • Provide guidance and support to teams on regulatory matters, including interpretation of regulatory requirements and development of regulatory submissions.
  • Manage and oversee the development and implementation of regulatory processes and systems, including quality management systems, document control systems, and change control systems.
  • Ensure compliance with regulatory requirements and industry standards, including GxP, ISO 13485, and ISO 9001.
  • Develop and implement training programs to ensure that teams are aware of regulatory requirements and industry standards.
  • Collaborate with other departments to ensure that regulatory requirements are integrated into business processes and systems.

Requirements:

  • Extensive experience in regulatory affairs, including experience in leading global regulatory teams and developing and implementing global regulatory strategies.
  • Strong knowledge of regulatory requirements and industry standards, including GxP, ISO 13485, and ISO 9001.
  • Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and regulatory authorities.
  • Strong analytical and problem-solving skills, with the ability to interpret complex regulatory requirements and develop effective solutions.
  • Ability to travel as needed.

What We Offer:

Gilead Sciences, Inc. is an equal opportunity employer and welcomes applications from diverse candidates. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

How to Apply:

Please submit your application, including your resume and cover letter, to our website.

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