Manager of Regulatory Affairs, Consultant

Responsibilities

Regulatory Strategy:

- Contribute to the development and execution of regulatory strategies aligned with corporate objectives and timelines.

- Assist in planning and coordinating regulatory submissions and interactions with health authorities.

Regulatory Submissions:

- Manage the preparation, review, and submission of all components of regulatory submissions including INDs/CTAs and amendments, BLAs, annual reports, safety reports, etc.

- Prepare and coordinate company responses to queries from health authorities.

- Ensure regulatory documents are compliant with global regulatory requirements and guidelines.

Quality and Compliance:

- Collaborate with Quality Assurance and Regulatory teams to ensure adherence to GXP regulations and regulatory compliance.

- Support regulatory inspections and audits as needed.

Cross-Functional Collaboration:

- Collaborate with cross-functional teams, including Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, Technical Development, and other relevant departments, to align regulatory strategies with organizational goals.

- Serve as Regulatory lead for study-level management teams.

Regulatory Intelligence:

- Assess changes in the regulatory environment and effectively communicate their impact on our product development strategy.

Requirements

- Bachelor's or advanced degree in a relevant scientific field.

- Minimum of 2-5+ years of industry experience in Regulatory Affairs within the biotechnology or pharmaceutical sector.

- Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs.

- Experience with cell or gene therapy regulatory affairs.

- Experience with CTD/eCTD and life cycle management.

- High attention to detail, strong organizational skills, and project management capabilities.

- Effective communication and interpersonal skills, with the ability to collaborate effectively in cross-functional teams.

- Ability to adapt to a dynamic regulatory environment.