Associate Director, Regulatory Operations - Dossier Planning in Basking Ridge at Daiichi Sankyo

Job Description

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 15,000 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 Operations – Dossier Planning is responsible for the management and oversight of the US Dossier Planning team. The Associate Director provides leadership and oversight to create submission plans that result in high quality regulatory submissions and procedures including, but not limited to, original INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory Operations in developing processes and standards that will allow for seamless submission planning processes from a Global perspective. The Associate Director liases with Global RO counterparts and key internal stakeholders to develop strategic and tactical plans for harmonizing processes and systems for Global Dossier planning capabilities in all regions. In addition, the Associate Director will institute system processes and enhancements for planning utilizing current EDMS planning capabilities. The Associate Director will be an active participant on the Regulatory Operations Leadership Team.

Responsibilities

• Manages and develops internal US team members ensuring a balance between internal resources and use/need of external vendors to ensure flexibility in the planning of global complex submissions. Responsible for direct report FY objective and goal setting, in addition to the development of staff and providing continued training opportunities. Regularly assess resource needs (internal and external) based on the submission schedule.
• Oversees the planning of all Global complex regulatory submissions (NDAs, INDs, BLAs, MAAs, and supplements). Will act as an escalation point for direct reports when questions, issues, etc are raised on dossier planning/submission topics
• Collaborates with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. Lead a cross-functional team within DSPD RD to explore submission process optimization.
• Explore and institute ways to streamline/enhance planning capabilities while utilizing capabilities within our current EDMS environment. Identify opportunities to cross-train RO personnel in order to better support submissions and enhance our planning capabilities within current EDMS.
• Review and interpret regulatory guidelines.
• Continuing Education: Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions.

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 required or
• Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD) preferred Experience Qualifications

• 4 or More Years Experience in the pharmaceutical industry
• 1 or More Years of direct regulatory operations experience
• 1 or More Years of regulatory filing experience (e.g., IND, BLA, NDA, MAA, etc.) preferably including global submissions (e.g., EU MAA, Japan NDA, etc.) preferred

Travel - Ability to travel up to 10% In-house office position that may require occasional travel (global).

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.