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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Contract

Discipline: Operations

Location: United Kingdom

Proclinical is seeking a Regional Regulatory Hub Strategist to support regulatory CMC submissions, ensuring compliance with local regulations across various markets. The role focuses on complex site transfers and multi-market projects, requiring effective communication and strategic planning to meet global supply and commercial objectives.

Responsibilities:

Support regulatory CMC submissions for country acceptability and manage HA queries.
Focus on complex site transfers, legal entity name changes, and multi-market projects.
Ensure transparency and excellence in regulatory strategy execution.
Build cross-functional relationships and communicate regulatory timelines and strategies.
Produce and dispatch dossiers according to defined filing plans.
Manage regulatory activities and drive timely issue resolution.
Collaborate on post-approval strategy and execution.
Provide input on technical issues and ensure submission readiness.
Author local submission components as needed.
Coordinate with global strategists on regulatory queries.
Cultivate positive professional relationships and hold accountability for results.

Key Skills and Requirements:

Bachelor's degree in Chemistry, Pharmacy, or related life science; advanced degrees are advantageous.
Understanding of IDM regulatory environment (EU, UK, CH, EME, ANZ, Canada, Korea).
Expertise in managing complex site transfers.
Competence in CMC submissions and regulatory risk identification.
Knowledge of drug development practices and regulations.
Strategic, analytical thinking, and strong communication skills.
Teamwork and collaboration abilities. - Quality and compliance orientation.
Fluent in English, both written and spoken.
Experience in pharmaceutical regulatory affairs or compliance.

If you are having difficulty in applying or if you have any questions, please contact Caitlin Siljeur at c.siljeur@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

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