Director Regulatory Affairs Oncology

vor 7 Monaten

Munich, Deutschland Daiichi Sankyo Europe Vollzeit

To provide European regulatory strategy support for assigned projects, products and non-project work. Act as a specialist in the area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a multi-disciplinary global product team, providing expertise on regulatory matters. Represent Regulatory Affairs in external interactions (e.g. authorities, affiliates, partners, CROs) providing expertise on regulatory strategy to achieve regional and global goals.

**Roles & Responsibilities**:

- European regulatory strategy support for assigned projects, covering product development plans, clinical trials and Marketing Authorizations Applications (MAA) as well as product life cycle management
- European Regulatory Affairs representation on global project teams providing regulatory guidance and strategy and supporting EU MAA submissions
- Act as regulatory contact person for authorities for assigned projects
- Participate in assigned non-project tasks and process improvements
- Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders

**Education & Professional Experience**:

- Bachelor degree in Life Science or Medical Science; Degree in Pharmacy, Master and/or PhD preferred; Master Degree in Regulatory Affairs is a plus
- Experience of working in global environment as well as with National Health Agencies and EMA
- Proven ability to plan, coordinate and lead activities simultaneously on multiple project
- 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
- Excellent written and oral communication skills in English, second language preferred

**Why work with us?**:

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