Director, Regulatory Affairs Product Support & Maintenance in Bernards, NJ at DSI

Date Posted: 7/23/2018

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

Provide regulatory leadership, guidance and strategy to assigned projects, products and assigned non-project work. Lead product support and maintenance for assigned marketed products in DSI territories in a manner that is scientifically sound, commercially viable and in accordance with regulatory standards. Act as a specialist for specific fields of regulatory or therapeutic knowledge. Represent West RA in internal and external interactions (e.g. project teams, working teams, health authorities, affiliates, partners).

Responsibilities

1. Provide leadership and guidance to the DSI Product Support & Maintenance team and the RA staff in DSI affiliates. Serve as a mentor and coach to team members. Develop internal talent to support West RA project capabilities. Serve as a deputy/delegate for the Head of Product Support & Compliance RA if needed. Lead and guide the product support execution staff in DSI. Lead and support education of pharmaceutical fellows.
2. Define and implement Local and/or Global RA strategy for assigned marketed products in the DSI territories. Lead and coordinate all required life-cycle management and maintenance processes for assigned marketed products such as new submissions in late tier countries, re-submissions, variations and renewals including affiliate and partner management. Lead and manage divestment processes and due diligence to marketed products. Be responsible for response to issue management and queries from Health Authority agencies to satisfactory conclusions. Provides business advice, context and groundwork for scientific and commercial development.
3. Lead maintenance and life-cycle management projects for DSI territories and be accountable for their effective implementation. Define project resource needs. Collaborate effectively with other RA functions (Operations and CMC) for optimal resource allocation. Ensure effective project support including:
  • Coordinate work with internal and external staff
  • Prepare and review regulatory documents for submission
  • Attend and organize operational meetings
  • Manage affiliate, partner and vendor oversight
4. Collaborate with all disciplines within the Daiichi Sankyo organization to obtain and/or provide information/data for regulatory submissions i.e. clinical, preclinical, pharmaceutical development, supply chain and clinical safety and pharmacovigilance
5. Manage and maintain relationships with DSI Commercial, DSI Affiliates, manufacturing sites, Supply Chain and CSPV, to ensure that regulatory activities and business needs are aligned. Ensure effective risk analysis for the DSI business continuity. Collaborate closely with RA Quality Management and ensure regulatory compliance within DSI territories for assigned marketed products.
6. Serve as a PMRA member, coordinate work and share information, participate in sub- teams. Oversee and manage non-product/project-related activities
7. This role may supervise regular or contract staff.

Qualifications

Education
  • Bachelor’s degree in Life Science or Medical Science, Pharmacy degree preferred; PhD or Master’s Degree a plus.
Experience
  • Minimum of 10 years experience in the pharmaceutical industry with 5-8 years of direct regulatory affairs experience with emphasis on Life-Cycle Management and Maintenance of US and ex-US licenses. Proven experience in a strategic leading role and submissions experience in US and other ex-US markets.
  • Working knowledge of laws, regulations and guidelines is essential. Experience working in a global, international regulatory environment.
  • Understanding of drug development and regulatory processes. Ability to interact effectively with FDA and other agencies. Ability to provide technical input, proven ability to plan, coordinate and lead activities simultaneously on multiple projects.
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.