Manager of Regulatory Affairs, Consultant

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

Join a pioneering biopharmaceutical environment focused on developing innovative cell therapies for patients living with autoimmune diseases.
In this six-month consulting engagement, you will contribute to the regulatory strategy and execution of clinical and nonclinical development programs.
You will oversee key regulatory submissions, ensuring accuracy, quality, and compliance with applicable global requirements.
Working closely with cross-functional teams, you will help align regulatory activities with scientific objectives and development timelines.
You will also support interactions with health authorities, respond to regulatory inquiries, and contribute to inspection readiness.
This role offers an opportunity to apply your regulatory expertise in a dynamic, research-driven environment at the forefront of cell therapy innovation.
The ideal candidate combines strong technical knowledge, attention to detail, and a collaborative approach to advancing complex therapeutic programs.

Accountabilities

Regulatory strategy: Contribute to the development and execution of regulatory strategies aligned with organizational objectives, product development plans, and project timelines.
Submission management: Coordinate and manage the preparation, review, and submission of regulatory documentation, including INDs, CTAs, amendments, BLAs, annual reports, and safety reports.
Health authority interactions: Prepare and coordinate responses to regulatory questions and requests, ensuring timely, accurate, and consistent communication with relevant authorities.
Regulatory compliance: Ensure regulatory documents comply with applicable global guidelines, ICH standards, and regional requirements, maintaining high standards of accuracy and quality.
Quality assurance and inspections: Collaborate with Quality Assurance and Regulatory Affairs colleagues to support GxP compliance, regulatory inspections, and audits as needed.
Cross-functional leadership: Partner with Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, and Technical Development teams to align regulatory activities with program objectives. Serve as the regulatory lead for study-level management teams.
Regulatory intelligence: Monitor changes in global and regional regulatory requirements, assess their potential impact on product development, and communicate relevant updates to stakeholders.
Project coordination: Support regulatory planning, submission tracking, and lifecycle management to ensure deliverables are completed accurately and within established timelines.
Requirements
Education: Bachelor's degree or advanced degree in a relevant scientific discipline.
Industry experience: Approximately 2–5 or more years of Regulatory Affairs experience within the biotechnology or pharmaceutical industry, with exposure to clinical and/or nonclinical regulatory activities.
Regulatory expertise: Strong understanding of global and regional regulatory requirements, ICH guidelines, and evolving regulatory trends.
Cell and gene therapy: Experience supporting regulatory activities for cell therapy or gene therapy products.
Submission experience: Familiarity with CTD/eCTD documentation, regulatory submissions, and product lifecycle management.
Technical capabilities: Ability to prepare, review, and coordinate complex regulatory documents while ensuring completeness, consistency, and compliance.
Project management: Strong organizational skills, attention to detail, and the ability to manage multiple priorities and deadlines in a fast-paced environment.
Communication: Excellent written and verbal communication skills, with the ability to convey regulatory requirements clearly and collaborate effectively with diverse stakeholders.
Adaptability: Ability to navigate evolving regulatory expectations, work independently, and contribute effectively to cross-functional teams.
Availability: Ability to commit to a full-time consulting engagement of approximately 40 hours per week for six months. Availability during West Coast business hours is preferred.
Benefits
Competitive hourly compensation: $75–$85 per hour, depending on experience and qualifications.
Remote flexibility: Work remotely from the United States, with a preference for candidates able to align with West Coast working hours.
Defined contract duration: Six-month consulting opportunity with a full-time schedule of approximately 40 hours per week.
Meaningful scientific impact: Contribute to the development of innovative cell therapies targeting autoimmune diseases.
Cross-functional collaboration: Work alongside experienced professionals across regulatory, clinical, manufacturing, quality, and scientific disciplines.
Professional development: Gain exposure to complex regulatory strategies, global submission requirements, and emerging cell therapy programs.
Innovation-driven environment: Support the advancement of potentially transformative treatments in a rapidly evolving biopharmaceutical field.