Regulatory Affairs Lead

Proclinical is seeking a Regulatory Affairs Specialist to lead the team. This will focus on managing regulatory proposal notifications, particularly for clinical trial submissions. The successful candidate will support the development of customer-focused regulatory content and budgets, and collaborate with regulatory strategists to define and integrate bid content. This position also involves representing Global Regulatory Affairs at business development meetings and ensuring proposals meet client needs and strategic discussions.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Triage incoming proposal notifications for the Regulatory Function, especially for clinical trial submissions.
• Develop and maintain regulatory proposal content and budgets.
• Collaborate with Regulatory Strategists to define bid content and integrate it into the bid strategy.
• Represent Global Regulatory Affairs at business development meetings.
• Ensure proposals and work orders include appropriate assumptions and meet client needs.
• Partner with the Regulatory function to ensure milestones and budgets are achievable.
• Provide input into regulatory strategy and timeline development for new study opportunities.
• Assist in establishing company standards for high-quality submissions.
• Support Regulatory leadership in monitoring performance and reporting key metrics.
• Participate in corporate quality initiatives across business units.
• Stay updated on laws, regulations, and guidelines governing drug development and approval.

Key Skills and Requirements:

• Bachelor's degree or equivalent expertise in a scientific or healthcare discipline.
• Proficiency in MS Office/Office 365.
• Fluent in English.
• In-depth understanding of the drug development process.
• Strong knowledge of regulatory activities, including submissions to Regulatory Authorities (e.g., INDs/CTAs, Scientific Advice Procedures, ODD, PIP, MAA/NDA, and post-approval submissions).
• Ability to understand and interpret clinical and pre-clinical study results for regulatory strategy.
• Familiarity with clinical trials methodology, including protocols and indications being studied.

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