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

Date Posted: 6/29/2018

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 responsible for providing oversight of the preparation, alignment and formulation of strategy for US, EU and/or global regulatory submissions. This position operates as the recognized/developing expert on the current Regulatory environment and 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 includes collaborating with global regulatory teams to ensure that products remain compliant around the world.

This position will include responsibility for the implementation of complex regulatory strategies at the European level which includes obtaining and maintaining European marketing authorizations for product(s), providing guidance and support to country Regulatory Affairs to obtain and maintain national marketing authorization of product(s).

This position mentors/instructs and provides guidance to internal and external direct/indirect reports, including providing EU regional regulatory advice to European and global project teams
responsible for delivery in a specific region to contribute to the drug project team's deliverables. This position pro-actively reviews and interprets regulatory guidelines with respect to impact on development programs. As a strategic leader the incumbent will develop and shape the strategic direction of the group, leading and implementing improved processes and performance.

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, and respond to regulatory authorities' questions with strict deadline within the frame of European procedure. 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, EU and/or global regulatory submissions. Advises on US, EU 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, EU 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, EU 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 highly 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.