Manager, Regulatory Affairs

4 weeks ago

Basking Ridge, New Jersey, United States Daiichi Sankyo Full time

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 Manager, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and coordination supports for global and US regulatory activities. The Manager 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 manager, RPM contributes to the RPM group by sharing best practice and escalating process and operational issues in a timely manner and continuous RPM process improvement with focus on quality, reliability, consistency and efficiency.

Responsibilities

Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory Operations (RO), and other key stakeholders (e.g. Protocol Amendments, Form 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.)Develop less complex Module 1 regulatory documents (e.g. cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissionsSupport GRL with scheduling regulatory meetings, preparing agenda and tracking action itemsResponsible for maintaining global health authority query (HAQ) tracker and archiving regulatory correspondencesSupport DSUR/PBRER preparation by attending Kick-off Meeting, coordinating and assisting in developing regulatory sectionsSchedule RRT meeting, creates response templates and coordinates processes for authoring and review of response as appropriateProvide support or coordinate other regulatory activities per direction from GRL and regulatory strategistsShare RPM best practices and contributed to RPM process improvementKeep current with regulatory and scientific regulations, guidelines and initiatives
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 Experience4 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 activities
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.

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