Job Description
Job Title:
Associate (m/f/d) Regulatory Affairs - EU Regulatory Procedural Management
Job Requisition ID:
1197
Posting Start Date:
3/16/26
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Location
The position can be filled at one of our European affiliates, with a preference for placement in Germany.
Purpose of the function
Provide support for EU Regulatory Procedural Management for assigned projects including all pre- and post-authorisation activities ensuring a smooth run of regulatory procedures as well as regulatory compliance. Act as a representative at project teams assigned, working with EU regulatory strategy leads, with affiliates, license partners and others to support procedural delivery of the projects.
Roles and Responsibilities
- Support assigned regulatory submissions during development and life cycle management, in alignment with Regulatory Strategists, for European and other assigned non-EU authorities
- Serve as a link between Regulatory Strategists, Product Support, and other disciplines in RA (e.g. RA-CMC, Labelling, Regulatory Operations)
- As assigned, represent EU Regulatory Procedural Management in global regulatory and development teams and provide EU regulatory procedural guidance and operational strategy for assigned projects
- As assigned by superior, act as the regulatory contact person for authorities pertinent to procedural matters
- Support internal communications on regulatory status for the assigned assets
- Ensure consistency across projects and global alignment/synergies
- Participate in assigned non-project tasks designed to enhance the operations and processes of Regulatory Affairs
- Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives
Education, Experience & additional Requirements
- University Degree in Pharmacy, Life Sciences, Natural Sciences or Medical Science, preferrably Master
- Master degree in Regulatory Affairs preferred
- Minimum of 1-2 years of experience in Regulatory Affairs; experience with EMA and CAPs preferred
- Experience of working in a global environment in interdisciplinary teams is a plus
- Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
- Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation
- Ability to develop and maintain good relationships, challenge views, present and argue cases in a professional and respectful manner
- Solution and detail-oriented; well organised and self-motivated
- Strong working knowledge of Microsoft Office
- Excellent written and oral communication skills in English, second EU 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.
Professionals