Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist focuses on this position reports into the associate director regulatory affairs and is based at reading (hybrid).

What the role involves

• This position reports into the Associate Director Regulatory Affairs and is based at Reading (hybrid).
• Prepares and submits regulatory submissions according to applicable EU regulatory requirements and guidelines for MRP or DCP to ensure maintenance and compliance of existing market.
• Collects and evaluates information on regulatory requirements for quality, preclinical and clinical data to meet applicable regulations.
• Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority, seeking opportunities to expedite regulatory approvals.
• Prioritizes, plans and monitors allocated projects against defined timelines.
• Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements.

Skills and requirements

• Relevant Bachelor's Degree or higher.
• 6+yrs related regulatory experience, ideally on non-prescription EU procedures (MRP/DCP).
• Able to build effective personal networks internally and externally.

Confirmed role details

• If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.

Additional role context

• Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated.
• Care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you!