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Job type: Contract

Discipline: Senior/Director & VP

Location: United Kingdom

Be the regional regulatory authority guiding global teams through complex compliance landscapes.

��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is seeking a Regulatory Affairs Senior Manager to support one or more products from a regional regulatory perspective. This position focuses on maintaining licenses for investigation and approved medicinal products while driving timely regulatory compliance.

Primary Responsibilities:

The successful candidate will collaborate with global teams to develop and execute regional regulatory strategies, ensuring compliance and effective agency interactions.

Skills & Requirements:

Strong knowledge of regional legislation and regulatory procedures for clinical trials, marketing authorizations, and post-approval changes.
Experience with policies, procedures, and SOPs related to medicinal products.
Comprehensive understanding of drug development and regulatory touchpoints.
Ability to resolve conflicts and develop actionable solutions.
Cultural awareness and sensitivity to work effectively across borders.
Proven ability to manage agency interactions and regulatory planning.
Expertise in scientific and technical aspects of regulatory affairs.

Key Responsibilities:

Advise global regulatory teams on regional considerations and ensure alignment with local requirements.
Plan and manage regulatory submissions, including clinical trial and marketing applications, in compliance with global and regional standards.
Implement product-related regulatory strategies and processes in accordance with national legislation.
Lead the development of regional regulatory documents and meetings in line with global strategies.
Provide guidance on regional regulatory mechanisms to optimize product development, such as accelerated approvals and paediatric plans.
Collaborate on regional product labeling strategies and negotiate with agencies to achieve desired outcomes.
Coordinate company responses to regulatory authority requests and communicate strategies effectively.
Assess regulatory risks and success likelihood, providing predictions and contingency plans.
Ensure compliance with regulatory commitments, including post-marketing requirements and paediatric obligations.
Share regulatory insights with global teams and ensure alignment across regional management.
Conduct regulatory research to stay updated on legislation, policies, and competitor activities.
Build and maintain relationships with regulatory agencies, documenting interactions and outcomes.
Support team collaboration and provide managerial leadership to direct reports, ensuring resource prioritization.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ��ý��ygfcmw��(�й�)վ��ֱ�ӽ� is acting as an Employment Agency in relation to this vacancy.

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