Senior Director, Regulatory Affairs – Client-Dedicated Embedded Role

About this role

Job Title: Senior Director, Regulatory Affairs – Client-Dedicated Embedded Role
Job Location: Remote, North Carolina, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Us as a Senior Director, Regulatory Affairs – Make an Impact at the Forefront of Innovation

The Senior Director, Regulatory Affairs provides senior-level regulatory strategy and leadership within a client-dedicated embedded model, serving as an integral member of the client’s development organization while remaining part of PPD, a Thermo Fisher Scientific company.
The successful candidate will be embedded within a clinical-stage biotechnology company developing innovative RNA-based therapeutics for oncology and immune-mediated diseases. The client operates in a highly entrepreneurial environment and is advancing a pipeline of novel therapeutic candidates based on an emerging technology platform.
This role will provide strategic and hands-on regulatory leadership across clinical and preclinical development programs, acting as a key regulatory partner to senior client stakeholders and cross-functional development teams. The Senior Director will be responsible for defining and executing global regulatory strategies, leading interactions with health authorities, and ensuring that development plans, data packages, and regulatory submissions support efficient advancement of the portfolio.
The position is particularly suited to an experienced regulatory leader who combines strong strategic judgment with the ability to operate hands-on in a small, fast-moving biotechnology environment.

What You'll Do

• Serve as the senior regulatory lead embedded within the client organization, providing day-to-day strategic and operational regulatory leadership across assigned development programs.

• Develop, maintain, and execute global regulatory strategies for clinical and preclinical assets, integrating regulatory requirements with clinical, nonclinical, CMC, and overall product development objectives.

• Provide regulatory leadership for innovative therapeutic modalities and platform-based development programs, identifying regulatory risks, opportunities, precedents, and potential accelerated development pathways.

• Act as a primary regulatory advisor to client senior leadership and cross-functional teams, contributing to development strategy, portfolio planning, program prioritization, regulatory risk assessment, and key development decisions.

• Lead preparation for and participation in interactions with global health authorities, including the US FDA, including CBER as applicable, EMA, TGA, and other regulatory agencies.

• Lead development of briefing packages, meeting requests, regulatory position papers, responses to health authority questions, meeting preparation activities, and post-meeting follow-up.

• Provide strategic oversight and leadership for regulatory submissions, including INDs/CTAs, amendments, regulatory designations, marketing authorization applications and lifecycle submissions, as applicable to the development stage of the portfolio.

• Ensure regulatory strategies and submission plans are appropriately integrated across clinical, nonclinical, CMC, technical operations, biostatistics, pharmacovigilance, and other relevant functions.

• Partner closely with R&D, Clinical Development, Technical Operations/CMC and other functional leaders to ensure study designs, development plans, and data packages are suitable to support regulatory interactions and future submissions.

• Provide regulatory assessment of emerging data and development scenarios and recommend pragmatic strategies to address regulatory challenges while maintaining scientific and regulatory rigor.

• Identify opportunities for expedited and facilitated regulatory pathways, including, where appropriate, Breakthrough Therapy, RMAT, Fast Track, Orphan Drug and other relevant regulatory designations or mechanisms.

• Support development of the client’s regulatory capabilities, operating model, processes, and governance as required, with an emphasis on scalability, quality, efficiency, and fit-for-purpose execution.

• Coordinate regulatory activities performed through external vendors, consultants, or functional service providers and ensure appropriate quality, accountability, and integration of deliverables.

• Provide leadership and regulatory subject matter expertise across multidisciplinary teams, facilitating clear decision-making in an environment characterized by evolving priorities and limited organizational infrastructure.

• Maintain current knowledge of evolving global regulatory requirements, guidance, precedents, and regulatory science relevant to oncology, novel therapeutic modalities, RNA-based technologies, and platform development.

• Ensure regulatory activities and deliverables comply with applicable regulations, guidance, client requirements, and relevant PPD/Thermo Fisher Scientific procedures.

• Build strong and trusted relationships with client stakeholders and represent PPD professionally within the embedded client environment, ensuring high-quality delivery and effective communication of regulatory risks, decisions, and priorities.

Education & Experience Requirements

• Bachelor's degree or equivalent in a scientific, medical, pharmaceutical, or related discipline required; an advanced degree such as an MS, PharmD, PhD, MD, or equivalent is preferred.

• 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 for products from early development through later-stage clinical development and registration.

• Demonstrated experience with INDs and/or CTAs and major global regulatory…