Regulatory Strategy Senior Director - Remote

10+ years

$200,000 – $210,000

Remote, USA

10 Nov. 26, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Strategy Senior Director – Fully Remote (United States)

Job Title: Regulatory Strategy Senior Director
Location: Remote, United States (District of Columbia preferred)
Job Type: Full-Time
Category: Clinical Research
Experience Required: Minimum 10+ years of Product Development and Strategic Regulatory experience
Company: Thermo Fisher Scientific (PPD Clinical Research Services)

Position Overview

Thermo Fisher Scientific is a global leader in scientific innovation, enabling customers worldwide to improve health, safety, and environmental outcomes. Through our PPD® clinical research portfolio, we support clinical trials in more than 100 countries, offering laboratory, digital, and decentralized trial capabilities.

We are seeking a Regulatory Strategy Senior Director to guide clients through complex regulatory pathways and play a central role in accelerating global product development.

Role Summary

The Regulatory Strategy Senior Director provides high-level regulatory leadership across investigational and marketed products. This role is responsible for defining strategic regulatory approaches, advising clients, guiding cross-functional teams, and supporting programs from early development through regulatory submission and approval.

This is a fully remote leadership role requiring deep expertise in US regulatory processes, strategic planning, and multi-program oversight.

Key Responsibilities

Develop comprehensive regulatory pathways and strategies to optimize product development timelines.
Act as a subject matter expert by contributing to target product profiles, strategic assessments, clinical development plans, and integrated development strategies within Thermo Fisher’s Accelerator Drug Development solutions.
Define key regulatory milestones and core messaging to support approval of investigational and marketing applications.
Provide regulatory oversight for multiple programs and cross-functional portfolios.
Lead strategic planning for regulatory interactions, including Interact meetings, pre-IND meetings, and Type B, C, and D meetings.
Guide the preparation of IND, NDA, BLA, and other regulatory submissions.
Address complex challenges by applying advanced analytical and scientific evaluation.
Provide senior strategic direction to the Strategic Development Consulting team and support the creation of new service offerings.
Serve as an expert liaison between regulatory agencies and clients.
Represent the Strategic Development Consulting group in client discussions and cultivate long-term partnerships.
Support business development efforts to expand regulatory and cross-functional consulting engagements.
Contribute to thought leadership initiatives across the organization.
Maintain current knowledge of PPD and client SOPs, regulatory guidelines, and industry expectations.

Qualifications

Education

Advanced degree preferred (PhD, PharmD, MD, MS) in Chemistry, Biology, Pharmaceutics, Engineering, or related scientific disciplines.
Equivalent combinations of education, training, and experience will be considered.

Experience

Minimum 10+ years of strategic regulatory and product development experience.
Demonstrated progression of responsibilities and accomplishments in drug development.
Extensive experience with US regulatory requirements, including successful negotiation with Health Authorities.
Global regulatory experience is an advantage.
Experience in consultancy roles strongly preferred.
Proven ability to lead multiple complex projects simultaneously.
Deep understanding of end-to-end drug development life cycle.
Strong interpersonal, communication, and matrix team leadership skills.

Work Schedule

Standard Monday to Friday schedule
Fully remote work environment

Compensation and Benefits

Estimated Salary Range (District of Columbia):
$200,000 – $210,000 annually, plus eligibility for an annual performance-based bonus.

Thermo Fisher Scientific offers a comprehensive Total Rewards package, including:

National medical, dental, and vision plans
Health incentive programs
Employee assistance and family support programs
Tuition reimbursement and commuter benefits
Minimum 120 hours of paid time off (PTO)
10 paid holidays annually
Paid parental leave (3 weeks bonding + 8 weeks caregiver leave)
Life, accident, disability coverage
Retirement savings plan with competitive 401(k)
Employee Stock Purchase Plan (ESPP)

Why Join Thermo Fisher Scientific?

With more than 100,000 global colleagues, Thermo Fisher Scientific is built on the values of Integrity, Intensity, Innovation, and Involvement. Employees contribute to scientific breakthroughs, solve complex development challenges, and support patients worldwide.

This role offers the opportunity to influence global regulatory strategy, collaborate with high-level scientific teams, and contribute to advancing innovative therapies.

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Regulatory Strategy Senior Director - Remote

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