Executive Director Regulatory Affairs in Basking Ridge, New Jersey at DSI

Date Posted: 10/29/2019

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

This position is accountable for developing and driving regulatory policy and provides oversight of regional and/or global regulatory submissions and ensures strategies are in accordance with therapeutic area direction and corporate objectives. This position provides leadership and sets strategic global direction of the therapeutic area or other group as the key decision maker and/or arbitrator. This position provides oversight of all interactions with Health Authorities (HA) and cross-functional team members and leads complex FDA interactions. This position leads global regulatory or technical initiatives or acts as a Regulatory Affairs (RA) expert in cross-functional business initiatives. This position interfaces with Senior Scientific and Commercial executives at DSPD on key scientific and regulatory issues. This position plans, assigns and directs work for direct reports and manages competing priorities as appropriate. Additionally, this position interacts with RA team members, cross-functional team members, FDA Project Managers and/or Reviewers and may interact with ex-US Health Authorities. This position also interacts with other therapeutic area functional leads and senior managers and/or senior executives. This position serves as point of contact for regional and other external health authorities and responsible to ensure the efficient and effective management of the Health Authority relationship. This position is strategic, providing the vision and direction for the group. This position acts as a “change agent” within RA and is accountable for successful regulatory activities, acting as the therapeutic or global lead. This position’s leadership may apply to regional and/or global projects. This position motivates self and others to complete projects on time and reviews decisions that may be in conflict with regulatory norms.

Responsibilities:
  • Regulatory Knowledge: Leads the development of and drives regulatory policy to ensure compliance with highest Corporate and global Regulatory standards; provides global therapeutic area expertise and guidance.
  • FDA Interactions: Leads communications with FDA and other regulatory authorities as needed. Leads global health authority interactions, including appropriate documentation of interaction, decisions and outcomes. Leads complex strategy and executional planning. Develops and drives strategies for other HA interactions (e.g., EMA, PMDA, etc.).
  • Dossier Submissions: Accountable for the successful and timely execution of US and/or global regulatory submissions. Advises on US and/or global submission strategies and identifies deficiencies requiring further resolution. Reviews RA and related documents for approval.
  • Registration Strategy: Leads regional/global registration strategies. Reviews GRASP to ensure regional/global registration strategic alignment. Ensures regulatory regional/global registration strategies adhere to therapeutic area direction, corporate objectives and achieving local business goals.
  • Team Interactions: Provides US or global representation on project teams; leads global regulatory teams for complex projects. Leads global regulatory or technical initiatives or acts as a RA expert in cross-functional initiatives. Interfaces with senior Scientific and Commercial executives at Daiichi Sankyo Pharma Development on key scientific and regulatory issues. Provides guidance to project teams within the therapeutic area.
  • People Management: Plans, assigns and directs work for direct reports; sets direction and manages competing priorities as appropriate. Responsible for the hiring, development and retention of talent.

Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD, JD)
  • Experience in the pharmaceutical industry required with 12+ years direct regulatory affairs experience, including US regulatory experience
  • Experience with ex-US regulatory authorities desirable
  • Managerial experience required
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.