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Associate Director Regulatory Affairs
1 month ago
Join a Legacy of Innovation 110 Years and Counting
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Associate Director, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and drives coordination of global and US regulatory activities. The Associate Director RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely manner. The Associate Director, RPM is considered an expert for all RPM activities and processes and is responsible for independently leading regulatory project management activities without additional guidance. The Associate Director, RPM provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in RPM processes and suggesting and integrating operational and procedural excellence best practice into RPM processes to enhance regulatory affairs capabilities.
Responsibilities
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
Bachelor’s Degree. Preferably in a scientific disciplineAdvance degree (e.g. MS, PharmD, Ph.D) preferredWork Experience
4 or more years of overall related experience (education and/or industry) is preferred1 or more years of industry experience within regulatory is preferredOrganized and detailed orientedExcellent oral and written communication skillsAbility to collaborate effectively with key stakeholdersAbility to plan, coordinate and lead activitiesDaiichi 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.