Regulatory Strategy Senior Director – Remote
Location: Remote, District of Columbia, USA
Job Type: Full-time | Category: Clinical Research | Fully Remote
Join Thermo Fisher Scientific and Lead Strategic Regulatory Innovation
Thermo Fisher Scientific empowers scientific innovation that transforms global healthcare. Our Clinical Research Services (CRS) team, supporting the PPD® clinical research portfolio, delivers high-caliber expertise to accelerate drug development and bring life-changing therapies to market. Operating across 100+ countries, we offer laboratory, digital, and decentralized clinical trial solutions to address the world’s most challenging health needs.
We are seeking a Regulatory Strategy Senior Director to provide expert strategic guidance across regulatory pathways, drug development programs, and client portfolios. This is a fully remote role based in the United States.
Key Responsibilities:
As Senior Director, Regulatory Strategy, you will lead complex regulatory initiatives and advise clients on optimal product development strategies:
Define regulatory pathways and strategies to optimize investigational product development.
Serve as a Subject Matter Expert (SME) collaborating with cross-functional teams on target product profiles, strategic program assessments, clinical development plans, and integrated development plans.
Provide strategic oversight for regulatory interactions, including pre-IND, Type B/C/D meetings, and submissions such as INDs, NDAs, and BLAs.
Establish central regulatory messaging and essential milestones to support approval of investigational and marketed products.
Offer senior-level guidance to the Strategic Development Consulting team, improving workflows and delivering innovative client solutions.
Interface with regulatory agencies and clients at an expert level, representing PPD Strategic Development Consulting in advisory discussions.
Support business development by expanding the portfolio of regulatory and cross-functional consulting projects.
Participate in thought leadership initiatives, staying current with regulatory guidelines, SOPs, and best practices.
Required Qualifications:
Advanced degree (PhD, PharmD, MD, MS) in a science-related field (e.g., Chemistry, Cellular or Molecular Biology, Pharmaceutics, Process Engineering) preferred.
Minimum 10+ years of product development and strategic regulatory experience in the pharmaceutical industry, with a proven record of career advancement.
Extensive knowledge of U.S. regulatory requirements and successful Health Authority negotiations; global regulatory expertise is a strong advantage.
Demonstrated ability to lead multiple complex projects and coordinate Subject Matter Experts.
Strong understanding of the full drug development lifecycle.
Experience as a consultant strongly preferred.
Exceptional communication, interpersonal, and leadership skills, with a record of working effectively in matrixed teams.
Preferred Qualifications:
Experience advising on regulatory strategy for multiple therapeutic areas.
Familiarity with integrated development plans, portfolio management, and strategic consulting services.
Strong business development acumen in regulatory consulting.
Compensation and Benefits:
Estimated salary: $200,000 – $210,000 per year
Variable annual bonus based on performance
Comprehensive benefits including medical, dental, vision, paid parental leave, life and disability insurance
Retirement programs including competitive 401(k) plan and Employee Stock Purchase Plan (ESPP)
Paid time off: Minimum 120 hours PTO, plus 10 holidays annually
For full benefits details: Thermo Fisher Total Rewards
Experience Level: Senior / Executive – 10+ years in pharmaceutical product development and strategic regulatory leadership, with extensive experience advising clients on U.S. and global regulatory pathways.
Why Thermo Fisher Scientific:
Lead global projects that transform healthcare and patient outcomes
Collaborate with top-tier scientific and regulatory experts
Flexible remote work culture with emphasis on work-life balance
Opportunities for professional growth, thought leadership, and business development
Apply Now to join a global leader in regulatory strategy, innovation, and life-changing scientific solutions. Contribute to accelerating drug development while shaping the future of clinical research.
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Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Bangor | Brewer |New Jersey :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
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Netanya | Kfar Saba | Yavne | Tel Aviv | Be'Er Sheva |Remote :
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Rabigh | Jeddah | King Abdullah Economic City | Khulais | Najran | Riyadh |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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Niš |Bohemia :
Prague |Chile :
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Sarajevo |Singapore :
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