Proclinical is seeking a dedicated and strategic Global Regulatory Affairs Director/Senior Director. The successful candidate will be responsible for developing and implementing regulatory strategies, managing documentation systems, and maintaining interactions with regulatory agencies. This role involves a significant amount of cross-functional collaboration and requires a proactive approach to regulatory filing and negotiation.
Key Responsibilities
Lead EU regulatory strategy, submissions, label discussions, and secure approvals.
Provide Europe Region regulatory input to project teams and interface with Global Regulatory Teams.
Shape the global strategy in line with regional/commercial objectives.
Negotiate with health authorities.
Support the drug development strategy; define options for Scientific Advice/Pediatric Investigation Plan, create briefing packages and lead agency meetings.
Define Europe region filing strategy; identify risks and issues.
Ensure effective implementation of filing plan, publishing and archiving of documents.
Plan and track activities, especially submissions and key correspondence.
Review and approve product-related packaging to ensure regulatory compliance.
Deliver regulatory milestones including an assessment of risks and mitigations, emerging data, and the probability of success.
Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.
Lead regulatory process improvements and initiatives.
Key Requirements
Masters 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.
Experience in Oncology is preferred.
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.
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 at j.pawl@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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