Regulatory Affairs Manager – UK Affiliates

Regulatory Affairs Manager – UK Affiliates

Uxbridge (UK) – Hybrid

An exciting opportunity to join one of the most prestigious biotech’s in the industry and work as a country lead to join a growing regional team. This is an exciting opportunity to demonstrate your knowledge in managing regulatory processes for gaining marketing authorisation and maintenance of licences in the UK market, while also serving as a member of our EU regional team.

In this unique position you will get along with a wide and diverse range of colleagues across Regeneron, both locally, regionally, and globally.

Responsibilities

·       Lead and manage timely submissions of marketing applications and post-approval changes to the UK MHRA

·       Proactively manage the regulatory process and effectively negotiate with regulatory stakeholders at MHRA

·       Lead the regulatory process for clinical trials for UK as well as EU CTAs

·       Interpret and implement the regulatory strategy and communicates to country team

·       Co-ordinate regulatory review of promotional materials as and when needed

·       Maintain in-depth knowledge of local regulations and requirements

·       Ensure compliance with UK regulatory requirements and all appropriate local

·       Depending on your experience, supporting EU centralised products in the Irish market may also be in scope

Experience required

·       Bachelors or advanced degree in an appropriate scientific discipline

·       Experienced (approx. 3-4 years) UK regulatory professional having managed major submissions and approvals via MHRA regulatory pathways

·       Experience handling UK applications post-Brexit

·       Knowledge of clinical trial requirements and procedures

·       Ability to think strategically, sound commercial awareness and good knowledge of medicines development within EU

For more details please reach out to [email protected] or call 01189522797