Regulatory Strategy Senior Director - Remote

Thermo Fisher Scientific

3d•$200,000 - $210,000•Remote

About The Position

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.

Requirements

Advanced degree (PhD, PharmD, MD, MS) in a science related field (Chemistry, Cellular or Molecular Biology, Pharmaceutics or Process Engineering) preferred.
At least 10 years of Product Development/Strategic Regulatory Experience in the pharmaceutical industry with a demonstrable record of career advancement and drug development accomplishments
Significant knowledge of, and experience with US regulatory requirements with a proven track record for successful negotiations with Health Authorities. Wider global regulatory knowledge is an advantage.
Ability to lead multiple projects, co-ordinate with Subject Matter Experts and lead discussions with clients.
Demonstrated understanding of the entire drug development process is required.
Excellent communication and interpersonal skills and a track record of working effectively in matrixed teams.
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.

Nice To Haves

Experience as a consultant is strongly preferred.

Responsibilities

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.

Benefits

A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

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