Manager – Regulatory Affairs, Consultant

This is a fully remote position, open to applicants in United States.

📋 Description

• Contribute to the formulation and implementation of regulatory strategies that align with corporate objectives and timelines.

• Assist in the planning and coordination of regulatory submissions and interactions with health authorities.

• Oversee the preparation, review, and submission of regulatory documents, including INDs/CTAs, amendments, BLAs, annual reports, and safety reports.

• Prepare and coordinate responses from the company to queries raised by health authorities.

• Ensure that regulatory documents adhere to global regulatory requirements and guidelines.

• Collaborate with Quality Assurance and Regulatory teams to guarantee compliance with GXP regulations and overall regulatory adherence.

• Support regulatory inspections and audits as necessary.

• Work alongside Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, Technical Development, and other pertinent departments.

• Act as the Regulatory lead for study-level management teams.

• Evaluate changes in the regulatory landscape and communicate their implications on product development strategies.

• Report directly to the Executive Director of Regulatory Affairs.

⛳️ Requirements

• Bachelor's or advanced degree in a relevant scientific discipline.

• A minimum of 2-5+ years of experience in Regulatory Affairs within the biotechnology or pharmaceutical industries.

• Comprehensive knowledge of regulatory requirements, including ICH and regional regulations, along with an understanding of current global and regional trends in regulatory affairs.

• Experience in regulatory affairs related to cell or gene therapy.

• Familiarity with CTD/eCTD and lifecycle management processes.

• Exceptional attention to detail, strong organizational skills, and project management abilities.

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

• Capability to adapt to a fast-paced regulatory environment.

• Preference for West Coast working hours.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holidays.

• Opportunities for professional development and career advancement.

• Collaborative and innovative work environment.