OG

Director Global Regulatory Affairs (m/f/d)

Otsuka Pharma GmbH•Marketing
Frankfurt am Main, Hessen, DeutschlandVollzeitVor Ortvor 5 Tagen
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📄Stellenbeschreibung

We are seeking a highly experienced, strategic, and influential Director of Regulatory Affairs to provide leadership for the development and execution of global regulatory strategies across a diverse portfolio of innovative development and marketed products.

This senior leadership role offers an exceptional opportunity to shape regulatory direction, influence development decisions, and drive successful product registrations in major global markets, with a strong emphasis on Europe.

The Director will serve as a key regulatory leader and strategic partner to senior management, guiding cross-functional teams through complex regulatory challenges while ensuring regulatory excellence throughout the product lifecycle.

The successful candidate will lead the development and implementation of integrated global regulatory strategies, enabling efficient product development, accelerated approvals, lifecycle optimization, and sustainable compliance.

Working closely with Development, Clinical, CMC, Safety, Market Access, Commercial, and Global Regulatory colleagues, the Director will provide strategic leadership for major development milestones, portfolio prioritization, market expansion initiatives, and regulatory risk management.

The role will also contribute to organizational capability building, regulatory policy interpretation, health authority intelligence, and continuous improvement initiatives to enhance regulatory effectiveness and business performance.

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

Job-Übersicht

Veröffentlicht
8. Oktober 2026
Standort
Frankfurt am Main, Hessen, Deutschland
Beschäftigungsart
Vollzeit
Arbeitsmodell
Vor Ort

Unternehmen

OG

Otsuka Pharma GmbH

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