🧾 Job Title: Regulatory Strategy Senior Director
Location: Remote – District of Columbia, USA
Job ID: R-01332708
Job Type: Full-time
Category: Clinical Research
Remote Status: Fully Remote
Work Schedule: Standard (Mon–Fri)
Environment: Office
🌍 About Thermo Fisher Scientific
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a global impact. Our mission — to make the world healthier, cleaner, and safer — drives every innovation we deliver. Through our PPD® Clinical Research portfolio, we conduct trials in over 100 countries, integrating laboratory, digital, and decentralized clinical services to accelerate the development of life-changing therapies.
🎯 Position Overview
The Senior Director, Regulatory Strategy serves as a strategic advisor to clients, providing expert regulatory guidance for investigational and marketed products. This role defines regulatory pathways, oversees agency interactions, and leads cross-functional collaboration to optimize product development strategies and approvals.
🧠 Key Responsibilities
Strategic Leadership
Define and execute regulatory pathways and development strategies for investigational products.
Act as a Regulatory Strategy Leader and Subject Matter Expert (SME), contributing to:
Target Product Profiles (TPP)
Strategic Program Assessments
Clinical and Integrated Development Plans
Thermo Fisher’s Accelerator™ Drug Development solutions
Regulatory Oversight
Define key regulatory milestones and central messaging to facilitate IND, NDA, and BLA approvals.
Provide strategic oversight for agency interactions (e.g., Interact, pre-IND, Type B/C/D meetings).
Offer high-level guidance across multiple programs and portfolios.
Operational Excellence
Address complex, multi-dimensional problems requiring in-depth data analysis.
Direct the Strategic Development Consulting team to optimize workflows and develop new client offerings.
Maintain up-to-date knowledge of PPD SOPs, client directives, and global regulatory guidelines.
Client and Business Engagement
Serve as a senior-level liaison between clients and regulatory authorities.
Represent the Strategic Development Consulting group in client discussions, fostering long-term partnerships.
Support business development initiatives to expand regulatory and cross-functional consulting portfolios.
Contribute to thought leadership initiatives promoting Regulatory Strategy and PPD capabilities.
🎓 Qualifications
|
Requirement |
Details |
|---|---|
|
Education |
Advanced degree preferred (PhD, PharmD, MD, MS) in a science-related field such as Chemistry, Biology, Pharmaceutics, or Process Engineering |
|
Experience |
Minimum 10+ years of Product Development / Strategic Regulatory Experience with proven advancement in the pharmaceutical industry |
|
Expertise |
Strong knowledge of U.S. regulatory frameworks and successful Health Authority interactions; global regulatory experience advantageous |
|
Consulting |
Prior experience as a consultant preferred |
|
Leadership |
Demonstrated ability to manage multiple projects, coordinate SMEs, and lead client discussions |
|
Industry Knowledge |
Comprehensive understanding of drug development processes |
|
Soft Skills |
Excellent communication, interpersonal, and matrix leadership abilities |
|
Equivalency Clause |
Equivalent combinations of education, training, and directly related experience may be considered |
💡 Core Competencies
Strategic and analytical thinking
Executive-level communication and negotiation
Cross-functional leadership and collaboration
Decision-making under complex regulatory conditions
Client relationship management and business acumen
💰 Compensation & Benefits
Estimated Salary Range (District of Columbia):
💵 $200,000 – $210,000 annually
Incentives:
Eligible for annual variable performance bonus (based on company, team, and individual results).
Comprehensive Total Rewards Package includes:
Medical, Dental, and Vision Plans (with health incentives)
Employee Assistance & Family Support Programs (including tuition reimbursement & commuter benefits)
Paid Time Off: Minimum 120 hours PTO, 10 holidays, and paid parental leave (3 weeks bonding + 8 weeks caregiver)
Insurance Coverage: Life, accident, short- and long-term disability
Retirement Savings: Competitive 401(k) plan
Employee Stock Purchase Plan (ESPP) at a discounted rate
🔗 More info: Thermo Fisher Total Rewards
🌐 Why Join Thermo Fisher Scientific
Be part of a 100,000+ colleague global community united by shared values:
Integrity
Intensity
Innovation
Involvement
Work collaboratively to accelerate research, solve scientific challenges, and improve patient outcomes worldwide.
#StartYourStory with PPD, part of Thermo Fisher Scientific — where expertise meets purpose and every career shapes the future of global health.
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Birmingham |Alaska :
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Wilmington |Florida :
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Boise |Illinois :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |Kentucky :
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Frank Scottile Blvd |LA :
Baton Rouge | Monroe | New Orleans |Louisiana :
Lake Charles | Shreveport |Maine :
Bangor | Brewer |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
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Mexico |South Carolina :
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Kiel |Belgium :
Wavre |BULGARIA :
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Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Hubei :
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Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
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Croatia |Zagreb :
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Prague |Republic of Egypt :
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Tallinn |Chuuk :
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