Director, Regulatory Affairs Strategy - Basking Ridge , New Jersey, United States, 07920
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.
This position leads the preparation, alignment and formulation of a global regulatory strategy with direct accountability for US and/or Europe across the product lifecycle for DSI Oncology portfolio. Primarily leads product support and maintenance for marketed products in DSI territories, but also may support programs in all phases of development. Act as a specialist for specific fields of regulatory or therapeutic knowledge. Represent RA globally and regionally in internal and external interactions (e.g. project teams, working teams, health authorities, affiliates, partners).
- Maintains a high level of regulatory knowledge across the product lifecycle and provides regulatory advice
- Define and implement Local and/or Global RA strategy for assigned 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.
- Acts as single point of contact to FDA for products/projects. Liaises, negotiates and leads FDA and/or EMA interactions, including appropriate documentation of the interaction, decisions and outcomes with oversight from supervisor.
- Independently leads the preparation, coordination or monitoring of regulatory submissions. Interacts across Daiichi Sankyo to obtain and/or provide information/data for regulatory submissions.
- Leads the formulation of registration strategies for products/projects. Ensures US and/or EU registration strategies are designed and captured in the Global Regulatory Affairs Strategy Plan and ensures implementation of the strategy. Ensures registration strategies adhere to corporate objectives.
- Provides regulatory affairs representation on project teams; may lead regulatory sub-teams. May act as single point of RA contact on cross-functional teams; fosters a global view as a member of the project team.
- Mentors and provides guidance to junior RA staff in a matrix environment.
Bachelor's degree in Life Science or Medical Science, Pharmacy degree preferred; PhD or Master's Degree a plus.
Minimum 10 years of experience in the pharmaceutical industry with 5-8 years of direct regulatory affairs experience with emphasis on Submission of US and ex-US licenses. BLA experience a plus.
Proven experience in a strategic leading role and submissions experience in US and other ex-US markets. Support of Oncology products desirable.
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.
Director, Regulatory Affairs Strategy
R&D Regulatory Affairs