Manager, Regulatory Affairs

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

📋 Description

• Oversee advertising and promotional submissions (2253s) pertaining to the BLA and act as the Regulatory Affairs representative on the Promotional Review Committee.

• Convert local, regional, and international regulatory requirements into actionable plans in collaboration with cross-functional teams.

• Supervise the preparation, review, and submission of regulatory documents across non-clinical, clinical, and CMC modules for IND/CTA, BLA/MAA, and other global submissions.

• Manage e-submission vendors as necessary.

• Collaborate with contributing authors from various functional areas to develop submission content.

• Ensure the timely preparation of organized and scientifically valid applications.

• Engage with regulatory agencies on specified matters.

• Implement regulatory documentation infrastructure, including both paper and electronic submissions.

• Mentor, guide, and train direct reports.

• Travel up to 15% as required.

⛳️ Requirements

• Bachelor’s degree and over 5 years of directly related experience.

• Direct experience in the review of promotional materials and knowledge of FDA OPDP requirements.

• At least 5-7 years of experience in pharmaceutical Regulatory Affairs, specifically with drugs and biologics.

• Regulatory Affairs certification or equivalent training is preferred.

• Experience in the preparation, submission, and lifecycle management of investigational/marketing applications in eCTD format.

• Familiarity with US, EU, Health Canada, Australia, and ICH regulatory requirements.

• Proven experience in direct interaction with regulatory authorities.

• A Bachelor’s degree in Chemistry, Biology, Pharmaceutical Science, or a related field is preferred.

🏝️ Benefits

• Competitive Compensation including base salary and annual performance bonus.

• Flexible PTO, holidays, and parental leave.

• Generous healthcare benefits, HSA match, 401k match, employer-paid life and disability insurance, pet insurance, wellness discounts, and much more!