Thermo Fisher Scientific · 1 day ago
Regulatory Strategy Senior Director - Remote
United States
Part-time
Remote
Director/Executive
$200K/yr - $210K/yr
10+ years expThermo Fisher Scientific is a global leader in enabling customers to make the world healthier, cleaner and safer. The Sr Director, Regulatory Strategy will advise clients on strategic regulatory considerations for investigational products, define regulatory pathways, and provide oversight across programs and portfolios.
Research
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
Qualification
Required
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
Preferred
Experience as a consultant is strongly preferred
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
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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