Associate Director Regulatory Science

Associate Director, Regulatory Science

Location: Chatham, NJ (Onsite – 5 days per week)

Salary: $185-200k base plus 17% bonus plus Equity

Direct Reports – Yes

The Associate Director Regulatory Science will advance global clinical regulatory compliance for investigational and marketed products and manage the preparation, review, and finalization of submission packages and responses to Health Authorities. This role will contribute to INDs, CTAs, BLAs, MAAs, and other regulatory applications in accordance with local requirements.

Company Info

• Commercial-stage biotech company working in the Immunotherapy/Cell Therapy space with multiple offices in the US.
• Multiple late-stage products in the Oncology space.
• Expanding Global Organization with a growing international regulatory and commercial footprint.
  
  

Responsibilities

• Lead Health Authorities direct reports by delegating projects, establishing and meeting timelines, and ensuring high-quality work products.
• Manage day-to-day staff activities, including hiring and training new team members, coaching employees, and monitoring performance.
• Review clinical data, reports, and summaries for compliance with protocols, statistical analysis plans, monitoring guidelines, data management plans, and other clinical trial documents.
• Provide input into the design and reporting of company-sponsored clinical studies.
• Manage preparation of relevant clinical sections and written summaries for regulatory submissions, including INDs, CTAs, NDAs, BLAs, MAAs, and other applications.
• Create and maintain project plans for Health Authorities operations and support cross-functional teams in the preparation, analysis, and documentation of studies.
• Lead external stakeholder engagement throughout the submission lifecycle, coordinating with CROs, external regulatory consultants, subject matter experts, and key opinion leaders.
• Prepare and assign responses to Health Authority comments and clinical questions, maintain response timelines, and assemble final submission packages.
• Serve as a trainer for Regulatory Affairs SOPs, processes, and templates covering document review, preparation, QC, and finalization.
• Monitor regional and local Health Authority guidance, interpret amendments, and incorporate updated requirements into regulatory dossiers.
• Oversee version-control governance for regulatory documentation, including centralized repositories, naming conventions, change tracking, and final module approval prior to electronic upload.
• Develop and maintain product-development road maps based on projected approval dates.
• Perform ad hoc and cross-functional duties or projects as assigned to support business needs and professional development.
  
  

Requirements

• Bachelor's degree in life sciences or a technical discipline with 10+ years of relevant progressive experience; or
• Master's degree in life sciences or a technical discipline with 8+ years of relevant progressive experience; or
• Doctorate degree in life sciences or a technical discipline with 6+ years of relevant progressive experience.
• Experience managing staff required.
• Experience managing and preparing clinical modules for submission in eCTD format required.
• Experience in medical writing.
• Experience organizing responses to Health Authority information requests required.
• Expert knowledge of Health Authority guidance documents and requirements.
• Expert knowledge of clinical research, Good Clinical Practices, regulatory requirements and guidelines, and clinical documentation.
• Strong leadership, organizational, written and oral communication skills, with the ability to manage multiple changing deadlines and operate in ambiguity.
  
  

Preferred Experience

• Experience with regulatory submissions outside of the United States.
  
  

Why This Opportunity?

• Opportunity to help shape global clinical regulatory strategy for both investigational and marketed products.
• Lead and develop a Health Authorities team while working closely with scientific and cross-functional colleagues.
• Play a central role in major global submissions, Health Authority responses, and regulatory dossier quality.
• Join a growing public biopharmaceutical company focused on next-generation immunotherapy and cell-therapy platforms.
• Work onsite in Summit, New Jersey, within a collaborative Regulatory Affairs organization.
  
  

How To Apply

We’d love to see your resume, but we don’t need it to have a conversation.

Email tom@scientificsearch.com or message me directly to learn more.