Senior Manager, Clinical Regulatory Affairs in New York at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Clinical Regulatory Affairs based in the United States.

This role supports clinical regulatory strategy and execution for innovative in vivo CAR T and cell and gene therapy programs.
You will contribute to global regulatory submissions and health authority interactions across the U.S., Europe, and other international markets.
The position offers the opportunity to work on novel therapies designed to address serious diseases and complex unmet patient needs.
You will collaborate closely with clinical development, operations, medical writing, CMC, pharmacovigilance, nonclinical, and program management teams.
The role combines hands-on regulatory execution with strategic input across early- and mid-stage clinical development programs.
You will help anticipate regulatory risks, navigate evolving requirements, and support high-quality interactions with global health authorities.
This is an opportunity to make a meaningful contribution within a growing, science-driven biotechnology environment.

As part of the Clinical Regulatory Affairs function, you will help shape regulatory strategy and ensure timely, high-quality execution across clinical development programs.

• Support the development and implementation of global clinical regulatory strategies for assigned programs, including early- and mid-stage development plans.
• Prepare, review, and support submission of regulatory documents, including INDs, CTAs, protocol amendments, annual reports, briefing packages, health authority responses, and applicable components of marketing applications.
• Partner with clinical development, clinical operations, medical writing, pharmacovigilance, CMC, nonclinical, program management, and external regulatory consultants to deliver high-quality regulatory materials on time.
• Support planning and preparation for FDA, EMA, national competent authority, and other global health authority meetings, including briefing documents, questions, responses, meeting strategy, and post-meeting documentation.
• Provide regulatory input into clinical study designs, protocols, investigator brochures, informed consent documents, safety reports, and other clinical trial materials.
• Monitor regulatory requirements, guidance, precedents, and competitive intelligence relevant to oncology, immunotherapy, cell therapy, gene therapy, biologics, and rare or serious diseases.
• Identify regulatory risks and opportunities, recommend mitigation strategies, and help ensure development programs remain aligned with health authority expectations.
• Maintain regulatory submission plans, timelines, trackers, and supporting documentation to promote inspection readiness and effective lifecycle management.
• Contribute to the development and improvement of regulatory processes, templates, standards, and best practices as the function evolves.
• Represent Regulatory Affairs on assigned project teams and serve as a trusted regulatory partner to cross-functional stakeholders.

Requirements:

The ideal candidate brings hands-on clinical regulatory experience, strong regulatory judgment, and the ability to operate effectively in a fast-paced biotechnology environment.

• Bachelor’s degree in life sciences, pharmacy, regulatory affairs, or a related discipline required; an advanced degree is preferred.
• For Senior Manager level, 5+ years of relevant Regulatory Affairs experience.
• For Associate Director level, 8+ years of demonstrated experience supporting clinical-stage drug, biologic, cell therapy, oncology, immunology, or rare disease programs.
• Hands-on experience with FDA submissions and interactions, including INDs, protocol amendments, annual reports, safety reports, briefing packages, and responses to information requests.
• Experience supporting EU and broader global clinical trial applications and health authority interactions, including CTAs, substantial amendments, and engagement with EMA or national competent authorities.
• Working knowledge of ICH guidelines, FDA regulations, EU Clinical Trials Regulation requirements, GCP, and global clinical development standards.
• Experience within biotechnology, pharmaceutical, cell therapy, or gene therapy environments is preferred.
• Ability to interpret regulatory guidance, evaluate its implications for development programs, and communicate clear recommendations to cross-functional teams.
• Strong understanding of clinical regulatory strategy and regulatory operations across U.S., EU, and global markets.
• Excellent written and verbal communication skills, including the ability to develop clear regulatory documents and executive-level summaries.
• Strong project management, organization, and prioritization skills, with the ability to manage multiple deliverables in a dynamic environment.
• Collaborative approach with the ability to influence without authority and build effective relationships across functions.
• Strong judgment, attention to detail, and ability to identify regulatory issues early and develop practical solutions.
• Comfortable working in a growing organization where processes are evolving and team members are expected to be hands-on, adaptable, and accountable.
• Commitment to patient-focused drug development, quality, compliance, and scientific integrity.
• Ability to travel as needed and work evenings, holidays, or weekends when required.
• If based in Seattle, ability to work onsite at the local office two days per week.
• Ability to sit for prolonged periods.

Benefits:

• Senior Manager base salary: $159,800–$197,400 annually.
• Associate Director base salary: $164,500–$202,650 annually.
• Competitive medical, dental, and vision insurance plans.
• 401(k) plan through Fidelity with a 100% company match on the first 4% of employee deferrals.
• Generous paid time off policy.
• Employee commuter benefits.
• Cell phone stipend.
• Opportunity to contribute to innovative clinical-stage programs focused on serious diseases and significant unmet patient needs.
• Collaborative and science-driven biotechnology environment.
• Growing organization offering opportunities to contribute to evolving regulatory processes and practices.