Associate Regulatory Affairs

vor 2 Wochen

Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

**Passion for Innovation. Compassion for Patients.**:
***Associate Regulatory Affairs - EU Regulatory Procedural Management (M/F/x)***:

- limited until 31.10.2024 -**:
**The position**:
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 lifecycle 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, Clinical Trial Office)
- 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 manager, 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

***Personal skills and professional experience**:

- University degree in Pharmacy, Life Sciences, Natural Sciences or Medical Science, Master preferred; Master degree in Regulatory Affairs is a plus
- Minimum of 1-2 years of experience in Regulatory Affairs; experience with EMA and CAPs is a plus
- Experience of working in a global environment in interdisciplinary teams
- 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

**What we offer**:
**Working at Daiichi Sankyo**:
At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.

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