Director (m/f/d) Regulatory Affairs - Lead EU Regulatory Procedural Management

Director (m/f/d) Regulatory Affairs - Lead EU Regulatory Procedural Management

Job Requisition ID: 945 | Posting Start Date: 2/2/26

Purpose of the function With emphasis on product development and regulatory life cycle management in Europe and International (EU and non-EU) provide regulatory leadership, guidance and procedural focused strategy and support to assigned projects in a manner that is scientifically sound, commercially viable and in accordance with regulatory standards. In this role, lead EU and International Regulatory Procedural Management, providing regulatory oversight and ensuring smooth run of regulatory procedures and regulatory compliance. Represent RA and/or DSE in internal and external interactions (e.g. project and working teams, affiliates, license partners, authorities, industry associations) pertinent to regulatory procedural management. Lead or support projects to enhance the functionality and improve procedural processes of the organization and/or to adapt to a regulatory environment ( non-project projects ). Act as a specialist within the area of EU Regulatory Procedural Management.

Roles and Responsibilities

Lead the Regulatory Procedural Management team in the EU and International serving as a link between Regulatory Strategists, and other disciplines in RA (e.g. Labelling, RegOps, Affiliates, CT office) and in R&D and in the business units.

Represent EU and International Regulatory Procedural Management in global regulatory and development teams and provide regulatory procedural guidance and operational strategy for assigned projects.

Plan, lead and manage assigned regulatory submissions during development and life cycle management, in alignment with Regulatory Strategists, to European and other assigned non‑EU authorities.

Determine the required documentation.

Ensure adherence of regulatory procedural requirements.

Coordinate preparation of and prepare and author procedural regulatory documents, review regulatory and related documents from a procedural perspective.

Direct activities required for timely and accurate submission and work closely with supporting functions such as Medical Writing, and other disciplines in RA (e.g. Labelling, RA‑CMC, RegOps, CT office).

Support and coordinate HA and internal meetings.

Work closely with Project Management agreeing delivery timelines, planning and tracking.

Act as regulatory contact person for authorities for assigned procedures.

Support internal communications on regulatory status for the assigned assets.

Ensure consistency across projects and alignment/synergies with the US RPM role.

Participate in or lead assigned non‑project tasks designed to enhance the functionality and processes of RA.

Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives.

Communicate important changes and trends within RA and other functions when relevant.

Design and revise SOPs and SOIs if required.

Mentor/instruct and provide guidance to internal and external (in‑direct) reports including consultants and vendors.

Plan, assign and direct work; manage competing priorities as appropriate.

Education & Experience

University Degree (Bachelor, Master, State Examination, Diploma) in pharmacy, medicine, life or natural science required.

University Degree Post‑doctorate or professional experience in pre‑clinical research or clinical development, a TOPRA diploma preferred or Master (e.g. chartered) in Regulatory Affairs or further pharmaceutical specialization (e.g. “Fachapotheker für Arzneimittelinformation”) is preferred.

At least 8 years working experience in pharmaceutical industry, in Clinical Research Organizations or in a regulatory authority with at least experience in regulatory affairs with an emphasis on clinical trial applications, regulatory pre‑submission and post‑approval activities and preparation of new Marketing Authorization in Europe (EU and non‑EU).

Experience in paediatric development is preferred.

Experience of working in a European or global regulatory environment and interacting with regulatory authorities.

Skills and additional Requirements

Excellent interpersonal skills.

Ability to communicate and work across functions effectively in a multinational organization to accomplish results.

Be “detailed‑oriented” with a good oversight, well organized and self‑motivated.

Proven ability to plan, coordinate and lead activities simultaneously on multiple projects.

High ethical behaviour.

Understanding of drug development and regulatory processes.

Ability to interact and communicate effectively with regulatory authorities.

Excellent written and verbal communication skills in English, German and a third language preferred.

Why work with us? Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for the better. We can only achieve this ambitious goal together. That is why we foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the opportunity to grow, think boldly, and contribute your ideas. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application. Apply now.

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