Senior Director, Regulatory Affairs Strategy - Oncology in Bernards, NJ at DSI

Date Posted: 8/2/2018

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary

This position is responsible for providing oversight of the preparation, alignment and formulation of strategy for US and/or global regulatory submissions. This position ensures regulatory strategies adhere to therapeutic area direction and corporate objectives. This position provides oversight of or primary contact for interactions with Health Authorities (HA) and cross-functional team members and leads complex FDA interactions. This position mentors/instructs and provides guidance to internal and external direct/indirect reports. This position pro-actively reviews and interprets regulatory guidelines with respect to impact development programs. Additionally, this position interacts with Regulatory Affairs (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. This position serves as point of contact with external health authorities. This position provides oversight of regulatory activities, leads or directs complex regional and/or global projects and focuses on big picture strategic decisions and problem solving. This position provides leadership and sets direction, acting as a key decision-maker and/or arbitrator on regional and/or global projects. This position motivates self and others to complete projects on time and can make day-to-day submission decisions without prior approval. This position refers decisions that may be in conflict with regulatory norms to a higher authority.

Responsibilities

Regulatory Knowledge: Pro-actively reviews and interprets regulatory guidelines with respect to impact development programs.

FDA Interactions: Communicates with FDA and other regulatory authorities as needed. Liaises, negotiates and leads complex FDA interactions, including appropriate documentation of interaction, decisions and outcomes. Leads routine strategy and executional planning. Contributes to development of strategies for other HA interactions (e.g., EMA, PMDA, etc.).

Dossier Submissions: Provides oversight of the preparation, coordination or monitoring of US and/or global regulatory submissions. Advises on US and/or global dossier submission strategies and identifies deficiencies requiring further resolution. Reviews RA and related documents for approval.

Registration Strategy: Provides oversight of the formulation of registration strategies for products/projects. Provides oversight to ensure US and/or global registration strategies are outlined in GRASP. Provides oversight to ensure registration strategies adhere to therapeutic area direction and corporate objectives.

Team Interactions: Provides US or global representation on project teams; may lead regulatory teams for more complex projects. Leads or supports global regulatory or technical initiatives or acts as a RA expert in cross-functional initiatives. Interacts with senior managers within Daiichi Sankyo on scientific and regulatory issues.

People Management: Mentors/instructs and provides guidance to internal and external direct/indirect reports.

Qualifications:

Education and Experience
  • Advanced degree (e.g., Masters, Pharm.D., Ph.D.) in a scientific discipline
  • Experience in the pharmaceutical industry required with 10-12 years direct regulatory affairs experience, including US regulatory experience
  • Experience with ex-US regulatory authorities desirable
  • Managerial experience desirable
Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.