Regulatory Affairs Expert

3 weeks ago

London, Greater London, United Kingdom Advanced Accelerator Applications (Italy) - S... Full time
About the Role

This position is a key part of our Regulatory Affairs team, responsible for ensuring compliance with regulatory requirements in the UK and globally.

Key Responsibilities:

The successful candidate will be responsible for providing effective regulatory support to our UK and global organisations, including:

  • Developing and implementing regulatory strategies to ensure compliance with medicines legislation and guidelines.
  • Providing advice and guidance on regulatory requirements and submissions to internal stakeholders.
  • Coordinating and submitting regulatory documents, including MA applications and life-cycle management.
  • Building and maintaining relationships with regulatory authorities and external stakeholders.
  • Contributing to the development of regulatory policies and procedures.

Requirements:

To be successful in this role, you will need:

  • A broad range of regulatory experience, encompassing CMC, Clinical and Commercial aspects in the ethical pharmaceutical industry.
  • Excellent communication and interpersonal skills, with the ability to build relationships with internal stakeholders and external regulatory authorities.
  • Strong analytical and problem-solving skills, with the ability to critically evaluate submission packages and negotiate with regulatory authorities.
  • Ability to work independently and as part of a team, with a strong focus on delivering results and meeting deadlines.

What We Offer:

This is a hybrid role, requiring a minimum of three days on-site in our London office. We offer a competitive salary and benefits package, as well as opportunities for professional development and growth.

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