Senior Regulatory Manager, Clinical Affairs

Hobson Prior is collaborating with a fantastic pharmaceutical organisation who are seeking for an individual to join their team on a permanent basis. The opening position that is currently available is for a Senior Regulatory Manager in Clinical Affairs. This role is an exciting opportunity to contribute to the development and implementation of regulatory strategies throughout the product lifecycle.

Responsibilities:

• Identify the need for new regulatory policies, processes, and SOPs and approve them.
• Evaluate regulatory risks of corporate policies.
• Provide strategic guidance for product development and planning throughout the product lifecycle.
• Analyse regulatory outcomes with initial product concepts and recommend future strategies and actions.
• Develop global regulatory strategies and update them based on regulatory changes.
• Conduct regulatory due diligence for potential and new acquisitions and advise management.
• Lead crisis management program development and implementation.
• Recruit, develop, and manage regulatory professionals.
• Review and approve labelling to ensure compliance.
• Represent regulatory affairs in product recall and recall communication process.
• Provide strategic input and technical guidance on regulatory authority queries.
• Negotiate with regulatory authorities during the development and review process to ensure submission approval.
• Write and edit technical documents.

Requirements:

• Experience with Medical Device 2a/2b/3.
• Experience working within the Diabetes Sector.
• Knowledge of Clinical Evidence.
• Global experience would be preferred.

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.

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