Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Discover Impactful Work:

This role will be an essential part of the global regulatory team. This role serves as a close business partner and facilitator of regulatory activities. This candidate will be responsible for developing sound regulatory strategies globally. This individual will be a key advisor of successful product launches and commercialization. In close collaboration with other functions and the broader regulatory team, this candidate is also responsible for: high quality and timely guidance in all areas of the business, from pre-approval activities, to filing, distribution, and post-approval regulatory activities, among others. The successful candidate must be based in the eastern time zone.

A day in the Life:Provide strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globallySupport in identifying the organization's suitable filing approach, and work together with various subject areas to achieve punctual filings.Oversee regulatory affairs vendors involved in marketing authorization filings and help ensure high quality interactions with regulatorsWorking with the regulatory team, provide hands-on contributions to regulatory filings including INDs, BLAs, and MAAs, and other areas as requestedProvide regulatory leadership with post-approval activities including application maintenance activities such as drug registration and listing, payment of program user feesMonitor, interpret, and relay alterations within the global regulatory environmentAct as the regulatory affairs business ally for local commercialization teamsPartner with medical, legal, quality, PV, and distribution teams to ensure regulatory input is provided in a timely matter to support business decisionsAct as the link between the strategy within the assigned project team and the wider global regulatory and development teams

Education:

Preferred: PhD or PharmD or equivalent experienceExperienceRequires a minimum of 10 years in regulatory affairs within biopharmaceutical companies, including 5-7 years in global leadership roles focusing on key regulatory regions like FDA, EMA, or PMDA.Prior experience working in rapidly growing pharmaceutical organizations is desirable

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, Abilities

Proficient in orphan drug development, knowledgeable about US regulations, and evolving guidelinesDemonstrated proficiency in orchestrating the production of vital regulatory documentation associated with the approval of medicines emphasizing the FDAAffinity with science and ability to interact with scientists and cliniciansExperience interacting with regulatory authorities, especially the FDA and EMAFamiliarity with current and emerging regulatory legislation, industry trends, and health care business practices globallyWell-developed organizational skills and project management abilities showcasing strengths in planning, delegating tasks, allocating resources, and prioritizing workloadsTrack record of successful interactions with regulatory and health authoritiesAbility to work well in a fast-paced, accountable environmentAbility to collaborate & work cross functionally with various teamsProven Leadership skills, with the ability to develop and lead teamsUse critical thinking and implement strategies, leading teams

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued