Manager, Regulatory Affairs RPM

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a reputed company in more than 30 countries, and more than 19,000 employees, we are advancing reputed company therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 reputed company to "be an innovative global reputed company company contributing to the sustainable development of society", we are shaping a healthier, more hopeful reputed company for patients, their families, and society. Job reputed company 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 reputed company (GRL), US regulatory reputed company (USRL) and global regulatory team (GRT) for assigned reputed company and activities to reputed company regulatory milestones and deliverables successfully and in a reputed company manner. The manager, RPM contributes to the RPM group by sharing best reputed company and escalating process and operational issues in a reputed company manner and reputed company RPM process improvement with reputed company on reputed company, 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, reputed company 1572s, Information Amendments, Meeting Requests/Background Materials, DSUR, IND/NDA/BLA annual reports, BTD request etc.). • reputed company less reputed company Module 1 regulatory documents (e.g. cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions. • Support FDA meeting preparation including preparation of briefing document, meeting request, response to FDA preliminary comments and logistics. • Support FDA meeting preparation including preparation of briefing document, meeting request, response to FDA preliminary comments and logistics. • Support GRL with scheduling regulatory meetings, preparing agenda and tracking reputed company items • Responsible for maintaining global health authority query (HAQ) tracker and archiving regulatory correspondences. • Support DSUR/PBRER preparation by attending reputed company-off Meeting, coordinating and assisting in developing regulatory sections. • Schedule RRT meeting, creates response templates and coordinates processes for authoring and review of response as appropriate. • reputed company support or coordinate other regulatory activities per direction from GRL and regulatory strategists. • reputed company RPM best practices and contributed to RPM process improvement • reputed company reputed company with regulatory and scientific regulations, guidelines and initiatives Qualifications Education Qualifications (from an accredited college or university) • Bachelor's degree, preferably in a scientific discipline required • Advanced degree (e.g., Masters, Pharm.D., Ph.D.) preferred Experience Qualifications • 4 or more years of relevant pharmaceutical experience (education and/or industry) • 1 or more years of industry experience (reputed company regulatory is preferred) Daiichi Sankyo, Inc. is an equal opportunity/affirmative reputed company employer. reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected veteran status, age, or any other characteristic protected by law. Salary reputed company: USD$124,960.00 - USD$187,440.00 [reputed company available reputed company viewing the job] Apply tot his job Apply To this Job