Senior Director, Regulatory Affairs – Client-Dedicated Embedded Role

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job 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 DoServe 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 RequirementsBachelor'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 AbilitiesExpert 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 a