Associate Director, Regulatory Services

Our client is seeking a Associate Director of Regulatory & Translational Services to support medical innovation from bench to bedside. This position is responsible for serving as a senior advisor to faculty, investigators, and institutional leadership on regulatory pathways and risk mitigation. This position will also manage a regulatory portfolio of highly complex and multidisciplinary projects. Responsible for assessing and advising faculty on project goals to then lead the development, review, and execution of regulatory strategy and operations for drugs and devices throughout the product lifecycle often employing innovative, adaptive, and tailored regulatory approaches.

The Associate Director will join a dynamic leadership team that collaboratively supports all aspects of early-stage and expanded use product development including nonclinical, quality, and clinical expertise. The AD will work closely with faculty, and institutional stakeholders to remove barriers and keep institutional leadership informed of research activities throughout the product lifecycle to facilitate development, mitigate institutional risk, and ensure adequate oversight and reporting of internal and external Sponsor vendors or collaborators.

The AD will manage and develop a team of regulatory associates, while simultaneously being responsible for their own projects of varying levels of complexity.

This position will evaluate new projects for resource needs and allocation as well as assessment of the unit’s strategic growth and development through collection and analysis of unit metrics and activities. In addition to product development support, the leadership team is responsible for establishing and maintaining Standard Operating Procedures, trainings and resources to support faculty members engaging in various aspects of product development including Regulatory Sponsorship, Manufacturing, and clinical or nonclinical activities. This includes training and consultation in alignment with institutional, local, state, and federal regulations and policies.

Responsibilities :

• Advise faculty, investigators, and institutional leadership on regulatory pathways, risk mitigation, and development considerations.
• Identify and remove regulatory or institutional barriers for project advancement
• Advise on regulatory pathways, evaluate applicable guidance and advise based on experience/knowledge for novel project
• Seek ways to leverage regulatory pathways to advance programs or initiatives.
• Lead, mentor, and develop a team of regulatory staff, fostering a culture of excellence, accountability, and continuous learning.
• Provide senior‑level oversight of staff performance, workload allocation, and professional development.
• Contribute to the development of the long‑term strategic vision and operationalize development of the OCR Regulatory Unit.
• Project scoping and financial management: Conduct OCR Regulatory intakes for new projects including scoping, resource assignment, and ongoing oversight of estimated to actual hours for you and your team
• Oversee preparation, review, and submission of INDs, IDEs, CTAs, amendments, annual reports, safety submissions, and meeting packages.
• Promote sponsor regulatory compliance with institutional, state, federal, and international requirements.
• Maintain expert‑level knowledge of evolving regulatory frameworks and assess their implications for unit operations.
• Serve as a senior contact with Health Authorities in regulatory discussions and meetings.
• Lead complex, multidisciplinary project teams and ensure seamless integration of regulatory strategy across clinical, quality, and nonclinical functions.
• Establish standards, policies, and best practices for document management and electronic submissions
• Lead multidisciplinary projects; integrate regulatory strategy across groups; act as senior SME for institutional initiatives Act as a senior regulatory subject matter expert for assigned programs and initiatives.
• Track and analyze unit metrics to inform continuous improvement, resource management, and operational strategy.
• Establish and maintain Sponsor Standard Operating Procedures, training and resources

Skill Set Requirements:

• Masters degree required, PhD preferred
• 7-10 years experience in drug and device development or equivalent combination of education and experience
• Significant experience in FDA regulatory affairs, translational research, product development, or a closely related field required
• Demonstrated experience developing regulatory strategies for early-stage programs and advancing products toward IND.
• Broad exposure to a variety of development programs, technologies, therapeutic areas, or product types.
• Ability to independently assess complex scientific and development questions and formulate strategic recommendations.
• Exceptional communication and interpersonal skills, with the ability to build credibility and trust with senior faculty, physicians, scientists, and other stakeholders.

Nice to Haves:

• Experience with medical devices
• Clinical development or clinical research experience.
• Experience working directly with the FDA or other regulatory agencies.
• Experience in an academic medical center, translational research institute, biotechnology, pharmaceutical, medical device, or similar environment.
• Experience leading multiple concurrent development programs or portfolios.
• Experience preparing for or participating in FDA meetings and IND submissions.