Senior Director, Regulatory Affairs – Client-Dedicated Embedded Role

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 submissions; experience supporting or leading BLA/MAA or comparable marketing authorization activities is highly desirable.
• Strong experience in oncology drug development is 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, is highly desirable.
• Experience with regulatory strategies for expedited development programs and designations such as Breakthrough Therapy, RMAT, Fast Track and/or Orphan Drug Designation is preferred.
• Demonstrated experience leading interactions with the FDA and other major global health authorities, including preparation for and leadership of formal regulatory meetings.
• Experience working in a small or mid-sized biotechnology organization, or demonstrated ability to operate effectively in a highly entrepreneurial and resource-constrained development environment, is strongly preferred.
• Previous experience providing senior regulatory leadership across multidisciplinary development teams.

Knowledge, Skills and Abilities

• Expert knowledge of global drug and biologics development regulations, regulatory strategy, and applicable ICH and regional regulatory requirements.
• Advanced understanding of regulatory requirements applicable to early and late-stage clinical development, marketing applications, and lifecycle management.
• Strong understanding of the regulatory considerations associated with oncology development and innovative or platform-based therapeutic modalities.
• Ability to translate complex scientific and development information into clear, pragmatic, and executable regulatory strategies.
• Demonstrated ability to independently assess development and regulatory risks, evaluate strategic alternatives, and provide recommendations to senior stakeholders.
• Strong strategic thinking combined with a willingness and ability to operate hands-on, including direct contribution to regulatory documents, health authority briefing materials, strategy documents, and submission planning.
• Ability to work effectively in an embedded client environment and rapidly develop credibility and trusted-advisor relationships with senior executives and cross-functional leaders.
• Demonstrated ability to operate effectively with a high degree of autonomy in a fast-paced, evolving and sometimes ambiguous environment.
• Excellent leadership, influencing, negotiation, judgment, and decision-making skills.
• Excellent written and verbal communication skills, including the ability to communicate complex regulatory issues clearly to scientific, operational, and executive audiences.
• Strong collaboration and interpersonal skills with the ability to work across organizational and functional boundaries.
• Ability to manage multiple complex priorities simultaneously and adapt regulatory strategies in response to evolving program data, business priorities, and regulatory expectations.
• Strong organizational and project leadership capabilities, with a focus on quality, accountability, and timely execution.
• Ability to effectively coordinate internal specialists, external consultants, vendors, and other regulatory contributors when required.

Client-Dedicated Embedded Model

This position is designed as a client-dedicated embedded regulatory leadership role. The Senior Director will work closely with and operate as part of the client’s organization, providing continuity of regulatory leadership and functioning as a trusted member of the client’s development team. The role requires the ability to balance the agility and hands-on approach expected within an emerging biotechnology company with the quality standards, regulatory expertise, and broader capabilities available through PPD and Thermo Fisher Scientific. The successful candidate will be expected to develop a deep understanding of the client’s technology platform, portfolio, organizational priorities, and ways of working and to provide regulatory leadership appropriate to the maturity and needs of the organization.

Working Conditions and Environment

Work is performed in an office, home-office, client, or clinical development environment, depending on the agreed working model. Regular interaction with client leadership and cross-functional development teams is expected. Domestic and international travel may be required, including travel for client meetings and health authority interactions.