Regulatory Affairs Manager

Proclinical is seeking a Regulatory Affairs Manager to lead the team, focusing on Marketed Products Development in Growth and Emerging Markets. This role involves developing strategies to ensure regulatory success, enabling patient access, and achieving market objectives. The successful candidate will be responsible for managing submissions and approvals, as well as life-cycle management of products.

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:

• Create strategies for success in Growth and Emerging Markets.
• Manage submissions, approvals, and life-cycle management for assigned programs.
• Communicate regulatory strategies and timelines effectively.
• Stay updated with regulations impacting drug development and registration.
• Provide regulatory expertise on non-clinical and clinical aspects.
• Ensure compliance with international product approval conditions.
• Build relationships with local and global regulatory teams and business partners.
• Evaluate new business opportunities and participate in due diligence.
• Provide strategic guidance on emerging trends and regulations.
• Lead or support meetings with Health Authorities and manage outcomes.
• Mentor team members and provide strategic guidance.
• Collaborate with market access colleagues to support product development plans.

Key Skills and Requirements:

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• Experience in regulatory affairs within the pharmaceutical industry.
• Knowledge of regulations governing drugs and biologics in growth and emerging markets.
• Experience in managing major regulatory filings and contributing to strategies.
• Strong communication, negotiation, and timeline management skills.
• Ability to work well in global teams and communicate with senior leadership.
• Experience managing relationships with external vendors is preferred.
• Willingness to travel for meetings.

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