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Director, Head of Global Dossier Planning â Regulatory Operations

4 months ago

Basking Ridge, 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 Groupâs 2025 Vision to become a âGlobal Pharma Innovator with Competitive Advantage in Oncology,â 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 Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team and leading all planning activities for Daiichi Sankyo major submissions globally. The Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited to original NDA/BLA/MAA,IND/CTA, supplements, annual reports as well as the rapid and efficient turnaround of time-sensitive submissions. The Director of Dossier Planning will collaborate with other functional areas to ensure that timelines for the submissions are jointly developed to foster a seamless flow of documents in order to meet submission timelines.

The Director will develop the process, tools and systems needed to build a core dossier for global submissions, they will liase with Global RO counterparts and key internal stakeholders to develop strategic and tactical plans for harmonizing processes of Global Dossier planning capabilities in all regions. The Director of Dossier Planning will report to Head of Global Regulatory Operations and be an active participant on the Regulatory Operations Leadership Team.

Responsibilities

Provide oversight for all Global complex submissions (NDAs, INDs, BLAs, MAAs and supplements). Lead the Dossier planning team and act as an escalation point for direct reports when questions, issues, etc. are raised on dossier planning/submission topics.Manages and develops internal talent ensuring a balance between internal resources and use of external vendors to ensure flexibility in the planning of global complex submissions. Mentor/coach and provide guidance to direct reports.Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings. Lead Dossier planning team meetings for major complex submissions and related activitiesLead a cross-functional team within RD to explore submission process optimization. Develop standard processes and tools for submission planning activities.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 in scientific, business or engineering discipline requiredMaster's Degree preferred.

Experience Qualifications

7 or More Years Pharmaceutical industry and Regulatory operations required.4 or More Years regulatory affairs including filing NDA and sNDA. BLA filing to FDA considered a plus..

Travel Ability to travel up to 20% 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.