Proclinical is seeking a Manager of Regulatory Affairs to support regulatory strategies and submissions for investigational applications, market applications, and life-cycle management in the gastroenterology and pharmaceutical sectors. This role involves collaboration with global, regional, and local teams to ensure patient access and compliance with applicable regulatory requirements.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Contribute to the development and execution of regional regulatory strategies to maximize product success and patient access.
• Collaborate with global, regional, and local teams to align program objectives and ensure timely approvals.
• Lead or support submission working groups and represent the region on global and project teams as needed.
• Support interactions with health authorities, including preparation for and participation in meetings.
• Monitor and interpret regional regulations and guidance to assess their impact on drug development, registration, and life-cycle management.
• Provide regulatory expertise throughout the product life cycle, including post-marketing compliance.
• Develop and maintain effective working relationships with internal teams, consultants, and business partners.
• Communicate regulatory strategies, submission plans, and timelines effectively to stakeholders.
• Ensure regulatory submissions and approvals are achieved on schedule.
• Support access initiatives by partnering with relevant functions to facilitate patient access strategies.

Key Skills and Requirements:

• A degree in a scientific field (BSc required; advanced degree preferred).
• Experience in drug regulatory affairs, particularly within the EU or emerging markets.
• Familiarity with regulations governing drugs and biologics across all development phases.
• Knowledge of advanced therapeutic medical products, such as cell and gene therapy, is advantageous.
• Strong analytical skills with attention to detail and the ability to make reasoned recommendations.
• Effective communication and relationship-building skills.
• Adaptability to changing circumstances and the ability to manage multiple priorities.
• Demonstrated ability to work inclusively and empathetically within diverse teams.

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

Apply Now:

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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.

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