Senior Director, US Regulatory Affairs Alliance Team Lead
: Job Details :

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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:

This role is responsible for providing regulatory strategic and tactical leadership, and alignment to ways of working on assets which are subject to an Alliance. This role will work on one of our cutting-edge assets within the alliance by effectively liaising, negotiating, and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the company's growth, thereby accomplishing corporate goals.

The role will be accountable for coordinating, mentoring, and providing guidance to direct reports (US RA strategists) across the alliance products to produce robust, innovative and cohesive regulatory strategies/plans that take into consideration the past learnings within Daiichi Sankyo on ADCs and the opportunities for synergies between the products. When goals are tactically misaligned or at risk for these assets, this leader will be responsible for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the assets. This role will be accountable for ensuring consistent and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory PMs assigned to alliance assets for operational matters.

Responsibilities:

• Develop and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing documents, breakthrough therapy designation requests, orphan drug applications and BLA annual reports. Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory filings.
• Strategize and plan for FDA meetings for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the full discussion for archiving.

• Serves as US RA strategy SME and coordinates, mentors/instructs, and provides guidance to direct reports (US RA strategists) across the alliance products to produce robust, innovative and cohesive regulatory strategies/plans that take into consideration the past learnings within Daiichi Sankyo on ADCs and the opportunities for synergies between the two products.

• Establishes clear and consistent ways of working across the alliance with regard to work that impacts US regulatory affairs. Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead for asset to reach resolution.

• Participate in global product team meetings to provide US regulatory support and guidance as needed and manage day-to-day regulatory activities.

• 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 chemistry, biology or other related discipline required and- PharmD in chemistry, biology or other related discipline preferred or- PhD in chemistry, biology or other related discipline preferred or- Master's Degree in chemistry, biology or other related discipline preferred

Experience Qualifications:

• Bachelor's Degree in chemistry, biology or other related discipline required
• PharmD in chemistry, biology or other related discipline preferred
• PhD in chemistry, biology or other related discipline preferred
• Master's Degree in chemistry, biology or other related discipline preferred

Experience Qualifications:

• 10 or More Years in the pharmaceutical industry required
• 7 or More Years in regulatory affairs; experience in US regulatory affairs from IND through NDA/BLA required

Travel: Ability to travel up to 20% In-house office position that may require occasional travel.

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.