Regulatory Strategy Senior Director - Remote

Sr Director, Regulatory Strategy

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.

About the role :

The Sr Director, Regulatory Strategy will be responsible for advising clients on strategic regulatory considerations for investigational products including :

• Defining regulatory pathways and strategies for optimized product development
• Acting as a regulatory strategy leader and Subject Matter Expert (SME) work with cross functional teams to chip in to the development of target product profiles, strategic program assessments, clinical development plans and integrated development plans, delivering on Thermo Fisher's Accelerator Drug Development solutions.
• Defining essential regulatory achievements and central messaging to assist in acquiring approval for investigational and marketing applications with regulatory agencies
• Providing strategic regulatory oversight across programs and portfolios
• Providing strategic regulatory oversight of regulatory interactions such as scheduled meetings (e.g. Interact, pre-IND, type B, C, D meetings, as well as regulatory submissions such as IND, NDA, and BLA)
• Work on problems of diverse scope where analysis of data requires in-depth evaluation of identifiable factors.
• Provide senior level strategic direction to the PPD Strategic Development Consulting team on ways to optimize work processes for delivering Consulting services and creating new client offerings
• Providing and facilitating an expert level interface between regulatory agencies and client
• Representing the Strategic Development Consulting group in discussions with clients and establishing relationships.
• Engage in and support the Strategic Regulatory Consulting team and its development and growth.
• Take an active role in business development to expand the portfolio of both standalone regulatory and cross functional consulting projects.
• Participate in and implement thought leadership initiatives that support and showcase Strategic Regulatory Consulting and the broader organization.
• Maintenance of up-to-date knowledge and understanding of PPD SOPs, relevant client SOPs / directives, and current regulatory guidelines as applicable to services provided.

Qualifications

Requirements :

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.

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.

Thermo Fisher Scientific is an EEO / Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

The salary range estimated for this position based in District of Columbia is $200,000.00$210,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and / or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes :