Manager, Regulatory Affairs Submission Management

Manager - Regulatory Affairs Submission Management

SRG is seeking a Regulatory Affairs professional with Submission Management skills & experience to assist a leading pharmaceutical company on a temporary basis. Join a dynamic regulatory affairs team and play a pivotal role in delivering complex regulatory submissions that support the development, approval, and life‑cycle management of innovative healthcare products.

• Contract:
  
  Temporary – 12 months (extension possible)
• Location:
  
  Maidenhead – hybrid working (or remote if needed)
• Rate:
  Inside IR35 – circa £22‑25 per hour (PAYE)

• Lead and manage complex regulatory submission projects, ensuring high‑quality dossiers are delivered on time and in line with regulatory requirements.
• Act as the primary regulatory submission management contact for cross‑functional project teams, providing guidance on processes, timelines, and deliverables.
• Coordinate and facilitate submission planning meetings, driving progress across multiple concurrent projects and stakeholders.
• Oversee publishing activities and collaborate with external publishing partners to ensure successful submission delivery.
• Perform quality reviews of published submissions, ensuring compliance with technical standards and regulatory authority requirements.
• Contribute to continuous improvement initiatives, enhancing regulatory processes, standards, and systems.

• Bachelor's degree or equivalent combination of education and relevant industry experience.
• Experience with in the pharmaceutical, biotechnology, healthcare, or related regulated industry.
• Strong project management skills, with experience managing complex, cross‑functional activities and competing priorities.
• Knowledge of regulatory operations, submission management, and/or submission publishing processes.
• Excellent written and verbal communication skills, with the ability to influence stakeholders in a matrix environment.
• Demonstrated leadership capability, including mentoring colleagues and driving process improvements. PMP and/or RAC certification is advantageous.

To apply, click and submit your profile or contact Theo Charles for further discussion.