Job Details
Job Title: Regulatory Affairs Lead– UK affiliates
Location: West London, UK (Hybrid)
Remuneration: Attractive salary and package
Role Type: Full Time, permanent position
An exciting opportunity to join a medium/large-sized pharmaceutical company and work as a UK and Ireland Lead. This is an great opportunity to demonstrate your knowledge in managing regulatory processes for gaining marketing authorisation and CTA to the maintenance of licenses in the UK and Ireland markets.
You will be accountable for leading the UK/IRE Regulatory Affairs team and to provide regulatory leadership, guidance and strategy for assigned marketed products and development projects in Ireland and the UK. This includes support and execution of regulatory activities..
Responsibilities:
•Act as the regulatory liaison and primary contact person for MHRA and HPRA, support or lead negotiations on regulatory issues with both agencies, organize meetings and teleconferences if required.
•Drive all UK affiliate related activities including Regulatory Affairs Strategies, leading pre submission meetings, health authority interactions and other pre approval activities.
•Lead and manage timely submissions of CTA and MAA for the UK and Ireland.
•In close collaboration with the Global and European Regulatory Team develop regulatory strategies and advice and provide clear guidance and information to internal and external stakeholders.
•Advise on national submissions and evaluate the content and adequacy of regulatory submissions, identify deficiencies requiring further resolution.
•Provide and prepare national information and documents for submission including documents required for labelling.
•Lead the UK RA team and provide regulatory guidance and strategy. Mentor and develop RA staff in the UK RA team.
•Ensure timely delivery of national regulatory submission, track and report national deadlines and submissions
•Maintain licenses of approved products, initiate and supervise implementation of changes; provide oversight and ensure regulatory compliance. Keep the headquarter informed about the status of submissions and implementation of changes.
Experience required:
·Bachelors or advanced degree in an appropriate scientific discipline
·Experienced (approx. 6+ 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
The role will require the right candidate to be based in the UK and be willing to commute to West London on a Hybrid bases. The position has an excellent great benefits package on offer.
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