Thermo Fisher Scientific
AD/Director, Global Regulatory Lead - FSP
Thermo Fisher Scientific, Raleigh, North Carolina, United States
Overview
AD/Director, Global Regulatory Lead - FSP This role will be an essential part of the global regulatory team. It serves as a close business partner and facilitator of regulatory activities, responsible for developing sound regulatory strategies globally and acting as a key advisor for successful product launches and commercialization. The candidate will provide high quality and timely regulatory guidance across pre-approval, filing, distribution, and post-approval activities, in collaboration with other functions and the broader regulatory team. The successful candidate must be based in the eastern time zone. Responsibilities
Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globally Identify suitable filing approaches and collaborate with various subject areas to achieve punctual filings Oversee regulatory affairs vendors involved in marketing authorization filings and ensure high quality interactions with regulators Contribute to regulatory filings including INDs, BLAs, MAAs, and other areas as requested Provide regulatory leadership for post-approval activities including application maintenance and related administrative tasks Monitor, interpret, and relay changes in the global regulatory environment Act as the regulatory affairs ally for local commercialization teams Partner with medical, legal, quality, PV, and distribution teams to provide timely regulatory input to support business decisions Bridge strategy within the assigned project team and the wider global regulatory and development teams Education
Preferred: PhD or PharmD or equivalent experience Experience
Minimum of 10 years in regulatory affairs within biopharmaceutical companies, including 5-7 years in global leadership roles focusing on FDA, EMA, or PMDA Desirable experience in rapidly growing pharmaceutical organizations Knowledge, Skills, and Abilities
Proficient in orphan drug development; knowledgeable about US regulations and evolving guidelines Experience producing regulatory documentation for medicines with emphasis on FDA interactions Ability to interact with scientists and clinicians; strong cross-functional collaboration Experience engaging with regulatory authorities, especially FDA and EMA Awareness of current and emerging regulatory legislation, industry trends, and health care business practices globally Excellent organizational and project management skills, with ability to plan, delegate, allocate resources, and prioritize Proven track record of successful interactions with regulatory authorities Ability to work in a fast-paced, accountable environment and collaborate cross-functionally Demonstrated leadership to develop and lead teams Strong critical thinking with ability to implement strategy across teams
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AD/Director, Global Regulatory Lead - FSP This role will be an essential part of the global regulatory team. It serves as a close business partner and facilitator of regulatory activities, responsible for developing sound regulatory strategies globally and acting as a key advisor for successful product launches and commercialization. The candidate will provide high quality and timely regulatory guidance across pre-approval, filing, distribution, and post-approval activities, in collaboration with other functions and the broader regulatory team. The successful candidate must be based in the eastern time zone. Responsibilities
Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globally Identify suitable filing approaches and collaborate with various subject areas to achieve punctual filings Oversee regulatory affairs vendors involved in marketing authorization filings and ensure high quality interactions with regulators Contribute to regulatory filings including INDs, BLAs, MAAs, and other areas as requested Provide regulatory leadership for post-approval activities including application maintenance and related administrative tasks Monitor, interpret, and relay changes in the global regulatory environment Act as the regulatory affairs ally for local commercialization teams Partner with medical, legal, quality, PV, and distribution teams to provide timely regulatory input to support business decisions Bridge strategy within the assigned project team and the wider global regulatory and development teams Education
Preferred: PhD or PharmD or equivalent experience Experience
Minimum of 10 years in regulatory affairs within biopharmaceutical companies, including 5-7 years in global leadership roles focusing on FDA, EMA, or PMDA Desirable experience in rapidly growing pharmaceutical organizations Knowledge, Skills, and Abilities
Proficient in orphan drug development; knowledgeable about US regulations and evolving guidelines Experience producing regulatory documentation for medicines with emphasis on FDA interactions Ability to interact with scientists and clinicians; strong cross-functional collaboration Experience engaging with regulatory authorities, especially FDA and EMA Awareness of current and emerging regulatory legislation, industry trends, and health care business practices globally Excellent organizational and project management skills, with ability to plan, delegate, allocate resources, and prioritize Proven track record of successful interactions with regulatory authorities Ability to work in a fast-paced, accountable environment and collaborate cross-functionally Demonstrated leadership to develop and lead teams Strong critical thinking with ability to implement strategy across teams
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