- 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 RA strategic plans. Provides oversight to ensure registration strategies adhere to therapeutic area direction and corporate objectives. Serve as Global Regulatory Lead or US regulatory lead on projects as needed
- 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: 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 required
- Advanced degree (e.g., Masters, Pharm.D., Ph.D.) in a scientific discipline preferredExperience Qualifications
- 10 or More Years Experience in the pharmaceutical industry
- 7 or More Years with direct regulatory affairs experience
- Managerial experience preferred
- Experience with ex-US regulatory authorities 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. -
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Senior Director Global Regulatory Affairs Strategy - Basking Ridge, United States - Daiichi Sankyo
Description
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 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 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
