Senior Director, Regulatory Affairs – Client-Dedicated Embedded Role

Thermo Fisher Scientific

. Serve as the senior regulatory lead embedded within the client organization .

Posted 10/6/2026full-timeUnited StatesSenior💰 $180,000 - $210,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in developing and executing global regulatory strategies for clinical and preclinical assets, with a strong focus on oncology drug development and interactions with global health authorities. Proven ability to lead multidisciplinary teams and manage complex regulatory submissions while maintaining compliance with applicable regulations.

Highest-signal resume keywords

Global Regulatory Strategy DevelopmentOncology Drug DevelopmentINDs/CTAs Submission ExperienceRegulatory Leadership and OversightExpert Knowledge of ICH Regulations

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AffairsClinical DevelopmentRegulatory SubmissionsRisk AssessmentRegulatory ComplianceRegulatory ScienceTherapeutic ModalitiesBiologics DevelopmentProject LeadershipData Assessment

Soft Skills

LeadershipCommunicationCollaborationNegotiationDecision-Making

Industry Keywords

BiotechnologyPharmaceuticalFDAEMATGABreakthrough TherapyFast TrackOrphan Drug DesignationRegulatory Affairs ExperienceClinical Trials

About the role

Key responsibilities & impact

Serve as the senior regulatory lead embedded within the client organization
Provide day-to-day strategic and operational regulatory leadership across assigned development programs
Develop, maintain, and execute global regulatory strategies for clinical and preclinical assets
Provide regulatory leadership for innovative therapeutic modalities and platform-based development programs
Advise client senior leadership and cross-functional teams on development strategy, portfolio planning, prioritization, risk assessment, and key decisions
Lead interactions with global health authorities, including the US FDA, CBER, EMA, TGA, and other agencies
Lead briefing packages, meeting requests, regulatory position papers, responses to health authority questions, meeting preparation, and post-meeting follow-up
Provide strategic oversight for regulatory submissions, including INDs/CTAs, amendments, regulatory designations, marketing authorization applications, and lifecycle submissions
Integrate regulatory strategies and submission plans across clinical, nonclinical, CMC, technical operations, biostatistics, pharmacovigilance, and other functions
Partner with R&D, Clinical Development, Technical Operations/CMC, and functional leaders
Assess emerging data and development scenarios and recommend strategies for regulatory challenges
Identify opportunities for expedited and facilitated pathways, including Breakthrough Therapy, RMAT, Fast Track, and Orphan Drug designations
Support development of the client’s regulatory capabilities, operating model, processes, and governance
Coordinate regulatory activities performed by external vendors, consultants, and functional service providers
Provide leadership and regulatory subject matter expertise across multidisciplinary teams
Maintain current knowledge of global regulatory requirements, guidance, precedents, and regulatory science
Ensure regulatory activities comply with applicable regulations, guidance, client requirements, and PPD/Thermo Fisher procedures
Build trusted relationships with client stakeholders and represent PPD professionally within the embedded client environment

Requirements

What you’ll need

Bachelor's degree or equivalent in a scientific, medical, pharmaceutical, or related discipline required
Significant progressive regulatory affairs experience within the biotechnology or pharmaceutical industry, typically 15+ years or an equivalent combination of education, training, and directly related experience
Extensive experience developing and executing global regulatory strategies from early development through later-stage clinical development and registration
Demonstrated experience with INDs and/or CTAs and major global regulatory submissions
Strong experience in oncology drug development required or strongly preferred
Experience with advanced or novel therapeutic modalities, such as RNA therapeutics, gene therapy, cell therapy, genetic medicines, or other complex biologic platforms, highly desirable
Demonstrated experience leading interactions with the FDA and other major global health authorities
Expert knowledge of global drug and biologics development regulations, regulatory strategy, and applicable ICH and regional regulatory requirements
Advanced understanding of regulatory requirements for early and late-stage clinical development, marketing applications, and lifecycle management
Strong understanding of regulatory considerations for oncology and innovative or platform-based therapeutic modalities
Ability to translate complex scientific and development information into clear, pragmatic, executable regulatory strategies
Ability to independently assess development and regulatory risks and provide recommendations to senior stakeholders
Ability to work effectively in an embedded client environment and develop trusted-advisor relationships
Ability to operate with a high degree of autonomy in a fast-paced, evolving, ambiguous environment
Excellent leadership, influencing, negotiation, judgment, decision-making, written communication, and verbal communication skills
Strong collaboration and interpersonal skills
Ability to manage multiple complex priorities and adapt regulatory strategies
Strong organizational and project leadership capabilities
Ability to coordinate internal specialists, external consultants, vendors, and regulatory contributors
Ability to travel domestically and internationally as required

Benefits

Comp & perks

Variable annual bonus based on company, team, and/or individual performance results
Choice of national medical and dental plans
National vision plan, including health incentive programs
Employee assistance and family support programs
Commuter benefits
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
Short- and long-term disability
Competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP), allowing eligible colleagues to purchase company stock at a discount