Director Global Regulatory Affairs (m/f/d)

Your area of responsibility:

• Contributes to the development, maintenance, and implementation of global regulatory strategies for assigned products, projects, submissions, or lifecycle activities under the direction of senior regulatory leadership
• Supports strategic and operational regulatory planning across development, registration, and post-authorisation phases, including identification of regulatory risks, options, assumptions, and mitigation approaches
• Supports preparation, critical review, coordination, and submission of regulatory documents, including clinical trial applications, marketing authorisation applications, amendments, variations, supplements, responses to health authority questions, and lifecycle submissions
• Provides regulatory input to cross-functional teams to support compliant development plans, clinical trial designs, submission documents, labelling considerations, and lifecycle activities
• Supports health authority interactions by coordinating input, preparing briefing materials, drafting responses, contributing to meeting strategy, and participating in meetings as required
• Reviews regulatory documents and project deliverables for quality, consistency, scientific accuracy, completeness, and alignment with agreed regulatory objectives
• Monitors evolving regulatory requirements, guidance, legislation, external expectations, and regulatory precedent to assess potential impact on assigned products, projects, and submissions
• Coordinates with internal functions, affiliates, external partners, vendors, consultants, and alliance stakeholders to support timely and compliant delivery of regulatory activities
• Provides regulatory input to due diligence, alliance management, business development, or external-partner activities when requested
• Contributes to regulatory governance discussions, submission-readiness activities, issue escalation, and decision-making forums as appropriate for assigned responsibilities
• Contributes to continuous improvement of regulatory processes, templates, standards, inspection-readiness practices, and ways of working
• University degree in Medicine, Pharmacy, Life Sciences, Chemistry, or another relevant scientific discipline; advanced degree preferred
• Relevant several years of experience in regulatory affairs within the pharmaceutical, biotechnology, medical device, health authority, or related environment
• Experience supporting clinical development, marketing authorisation applications, lifecycle management, and post-authorisation regulatory activities
• Sound knowledge of drug development, global regulatory requirements, applicable legislation, regulatory guidelines, and regulatory precedent
• Experience preparing, reviewing, or contributing to regulatory submissions such as CTA, IND, NDA, BLA, MAA, variations, supplements, amendments, and responses to health authority questions
• Experience supporting health authority interactions, submission planning, regulatory issue resolution, and lifecycle planning
• Experience working effectively with cross-functional teams and external partners in a matrix environment

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Quelle: Statistisches Bundesamt (Destatis), Tabelle; dl-de/by-2-0; eigene Berechnung