Senior Regulatory Submissions Manager

9 hours ago

London, Greater London, United Kingdom Cpl Life Sciences Full time

Job Description:

Associate Director Global Submissions Management

Cpl Life Sciences is seeking an Associate Director Global Submissions Management to lead the efficient operation of managing regulatory submission processes across the EU, UK, Switzerland, and Growth Market regions.

Responsibilities:

  • Strategically lead the regulatory submission management process, ensuring timely and compliant submission of regulatory dossiers, including MAAs, variations, renewals, and other filings.
  • Manage cross-functional teams to ensure alignment with corporate goals and objectives.
  • Maintain a high level of visibility within the organization, presenting on various GSM-related topics and emerging developments in the world of eCTD regulatory submissions.
  • Develop and maintain in-depth knowledge of EU/UK regulatory requirements, eCTD format, and the global submission process.
  • Manage complex projects, collaborate with cross-functional teams, and deliver results in a fast-paced environment.
  • Lead by example, demonstrating strong leadership, communication, and problem-solving skills, with a focus on driving operational excellence.

Requirements:

  • Minimum of a Bachelor's degree in a Scientific or Technical Discipline; Advanced Degree (MS, PhD) preferred.
  • 10 years of CORE regulatory operations/publishing/submission management experience.
  • Previous line management experience.
  • Strong communicator with the ability to lead presentations and senior discussions.
  • UK, EU, and emerging market experience.

Cpl Life Sciences offers an excellent opportunity to work with a leading pharmaceutical company at the heart of science and neuroscience development. The role comes with a competitive salary and package, including a bonus, car allowance, life assurance, pension scheme, and private healthcare.

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