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Director Regulatory Affairs Cmc

vor 2 Wochen

Pfaffenhofen an der Ilm, Deutschland Daiichi-Sankyo Europe Vollzeit

**Passion for Innovation. Compassion for Patients.**:
**Director Regulatory Affairs CMC (M/F/x)**:
**Purpose of the function**:
The Director RACMC will provide European regulatory CMC guidance and strategy for assigned products and will represent Regulatory Affairs CMC EU in internal and external interactions (e.g. global and local project teams, working teams, authorities interactions in scientific advices, CMOs). The function will lead the preparation of regulatory CMC documents during development and life cycle management as IMPDs and MAAs in a manner that is scientifically sound, commercially viable and in accordance with regulatory CMC standards. The function may act as a specialist for biological products in the EU regulatory CMC field. The function communicates EU and international regulatory requirements to authoring teams, develop the EU regulatory strategies and review dossiers and technical documents. The function and the team collaborates companywide within the global RACMC department and technical functions. The function is proactively influencing the internal, but also external regulatory affairs environment.

**Roles and responsibilities**:

- Lead regulatory teams to conduct preparation of M2 and M3 CTD documents for EU MAAs and IMPDs filings of new drugs, incl. Quality Overall Summary (QOS).
- Represent EU RACMC function in global RACMC and CMC development teams and provide CMC regulatory guidance and strategy
- Review CMC documents, develop regulatory strategies, provide risk assessments
- Lead the preparation and execution of Health Authority meetings
- Interpret, develop strategy and lead response preparation on Health Authorities information requests
- Keep close collaboration with global RACMC colleagues and technical experts, across all regions
- Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders
- Participate or lead assigned non-project tasks and process improvements
- Influence the EU regulatory landscape

**Personal skills and professional experience**:

- Master degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus
- Minimum of 8 years of experience in the pharmaceutical industry
- 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
- Experience of working in global environment in interdisciplinary teams
- Experience of leading interdisciplinary teams
- Solution and detail-oriented; well organised and self-motivated
- Excellent written and oral communication skills in English, German as a second language preferred
- Strong working knowledge of Microsoft Office

**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.