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Senior Director Global Regulatory Affairs Strategy Lead
1 month ago
Global Regulatory Affairs Strategy Role
Daiichi Sankyo Group is dedicated to creating and supplying innovative pharmaceutical therapies to improve healthcare standards and address unmet medical needs globally. With over 125 years of scientific expertise and a presence in over 20 countries, Daiichi Sankyo and its 18,000 employees worldwide draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Key Responsibilities:
- Lead a multidisciplinary Global Regulatory Team to develop global regulatory strategy and plans for assigned global projects, ensuring alignment with therapeutic area direction and corporate objectives.
- Represent Daiichi Sankyo's regulatory group in internal and external development project meetings, providing guidance to peers and cross-functional team members on strategic regulatory issues.
- Interface with clinical and pre-clinical groups, Regulatory CMC, and other appropriate groups within the company as needed, reviewing and interpreting regulatory guidelines, precedence, and competitive landscape with respect to impact on development programs.
Qualifications:
- Bachelor's Degree required.
- Advanced degree (e.g., Masters, Pharm.D., Ph.D.) in a scientific discipline preferred.
- 10 or More Years Experience in the pharmaceutical industry.
- 7 or More Years with direct regulatory affairs experience, including experience in regulatory submissions in Oncology.
- Managerial experience.
- Experience with ex-US regulatory authorities.
- Travel - Ability to travel up to 20%.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
