Director Global Regulatory Affairs (m/f/d)

Otsuka Pharma GmbH; Frankfurt; Sur place; EUR 150 000 - 230 000; Plein temps

Résumé du poste

Otsuka Pharma GmbH in Frankfurt seeks a Director of Regulatory Affairs to lead global regulatory strategies for a broad portfolio, with strong emphasis on Europe. The role partners with Development, Clinical, CMC, Safety, Market Access, and Global Regulatory to drive registrations and lifecycle management.

The incumbent will guide cross-functional teams, manage submissions, and influence development decisions while ensuring regulatory excellence across the product lifecycle and regions.

Qualifications

• University degree in Medicine, Pharmacy, Life Sciences, Chemistry or related field.
• Several years of regulatory affairs experience in pharma/biotech environments.
• Experience in clinical development, MAAs and lifecycle management.
• Solid knowledge of global regulatory requirements and guidelines.
• Experience with submissions such as CTA/IND/NDA/BLA/MAA and health authority responses.
• Experience coordinating health authority interactions and submission planning.
• Proven ability to work with cross-functional teams in a matrix environment.

Responsabilités

• Lead development and execution of global regulatory strategies for assigned products.
• Provide regulatory input to development plans, submissions, and lifecycle activities.
• Coordinate health authority interactions and preparation of briefing materials.
• Ensure inspection readiness and governance in regulatory processes.
• Collaborate with internal and external partners to deliver timely regulatory activities.
• Support risk assessment and regulatory issue resolution across projects.

Connaissances

Regulatory strategy

Cross-functional leadership

Submission planning

Health authority interactions

Lifecycle management

Formation

University degree in Medicine, Pharmacy, Life Sciences, Chemistry

Advanced degree preferred

Description du poste

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