Senior Director Regulatory Affairs (Remote)

Proclinical is seeking a strategic Global Regulatory Affairs Director/Senior Director. Reporting into the SVP, Regulatory Affairs, the successful candidate will be responsible for supporting the development and implementation of regulatory strategies, managing documentation systems, and maintaining interactions with regulatory agencies. This role will also involve leading EU regulatory strategy, submissions, and securing approvals.

Please note we are unable to accept applications from candidates who do not have right to work in the EU.

Responsibilities:

• Lead EU regulatory strategy, submissions (MAA/CTA), label discussions, and secure approvals.
• Provide appropriate Europe Region regulatory input to project teams and regularly interface with Global Regulatory Teams.
• Make recommendations to Global Regulatory and drug development teams to shape the global strategy in line with regional/commercial objectives.
• Negotiate with health authorities such as the EMA.
• Support the drug development strategy; define options for Scientific Advice/Pediatric Investigation Plan, create briefing packages and coordinate and lead agency meetings.
• Define Europe region filing strategy (including CP, MRP, DCP); identify risks and issues.
• Ensure effective implementation of filing plan, publishing and archiving of documents.
• Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.
• Lead regulatory process improvements and initiatives.

Key Skills and Requirements:

• Master's degree or above, major in biology, medicine or pharmacy related.
• RAC Europe certification is preferred.
• Previous experience of regulatory drug development or equivalent.
• European regulatory experience.
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.
• Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application.
• Demonstrated competencies of strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.
• Ability to work strategically within a business critical and high-profile development program.
• Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.

If you are having difficulty in applying or if you have any questions, please contact Jaeme Pawl at J.pawl@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.