Hobson Prior are looking for a Regional Regulatory Affairs, UK Liaison Associate Director for an exciting opportunity to join a leading biopharmaceutical company on a permanent basis in Slough.

Job Responsibilities:

• Accountable for UK-specific regulatory oversight on marketed and investigational biologic and NCE products.
• You will serve as the primary regulatory liaison between the MHRA and the company and will provide leadership and oversight of the transition of the MHRA through BREXIT to help ensure any impact on business continuity is minimised.
• Liaising with a contract organisation that provides the local affiliate regulatory resource to ensure alignment.
• Prepare and deliver regulatory operational plans for assigned projects/products within the broader EU region.
• Provide strategic and operational regulatory input and guidance in cross-functional teams and manage quality regulatory submissions to agreed project targets.

Key Skills:

• Must be able to work flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.
• Ability to coordinate multifaceted projects and to meet critical deadlines.
• Strong oral and written communication skills.
• Excellent meeting preparation and presentation skills.
• Effectively manage teams, meetings and negotiations with internal and external groups to progress corporate plans.
• Ability to manage and action direct reports.

Requirements:

• Minimum of 5 years of Regulatory Affairs experience within biotech/pharma industry with a preference for a successful track record in biologic and pharmaceutical product submissions.
• In-depth knowledge of the drug development, CTA, product registration processes and the MHRA.
• Demonstrated experience preparing chemistry, preclinical and clinical CTA submissions.
• Proven ability in project leadership and representing the company in formal meetings including presentations to and negotiations ideally with the MHRA.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.