Senior Manager Regulatory Affairs Oncology
Daiichi Sankyo Europe
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 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 development 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.
Professional experience & Education:
- Bachelor degree in Life Science or Medical Science; Degree in Pharmacy, Master and/or PhD preferred; Master Degree in Regulatory Affairs is a plus;
- Minimum of 8 years of experience in the pharmaceutical industry and minimum of 5 years of experience in global regulatory affairs with emphasis on late stage drug development and marketing authorization applications in Europe, experience with clinical trials, orphan drugs and pediatric clinical development;
- 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 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;
- Excellent written and oral communication skills in English, second language preferred.
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