Senior Manager Regulatory Affairs Oncology

Daiichi Sankyo Europe

Multiple Locations, Europe

The Position:

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. The position can be filled Europe-wide.

Roles and 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

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
Minimum of 8 years of experience in the pharmaceutical industry
Minimum of 6-7 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
Experience of working 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, gain the trust of others, challenge views and 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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