Regulatory Affairs Manager

Eagle Labs, Inc•Largo, FL

About The Position

The Regulatory Affairs Manager plays a critical role in ensuring that pharmaceutical and biotechnology products comply with all applicable regulatory requirements throughout their development and commercialization lifecycle. This position is responsible for leading the preparation, submission, and maintenance of regulatory documents to health authorities in the United States and potentially other global markets. The manager will collaborate closely with cross-functional teams including drug development, clinical operations, and product development to align regulatory strategies with business objectives. They will monitor evolving regulatory landscapes and provide expert guidance to ensure timely approvals and continued compliance. Ultimately, this role ensures that products reach the market efficiently while maintaining the highest standards of safety and efficacy.

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field.
Minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
Demonstrated experience with regulatory submissions and interactions with the FDA.
Strong knowledge of drug development processes, clinical trials, and regulatory requirements in the United States.
Excellent written and verbal communication skills.

Nice To Haves

Advanced degree (MS, PharmD, or PhD) in a relevant scientific discipline.
Experience with global regulatory submissions and international regulatory agencies.
Familiarity with electronic submission systems (eCTD).
Project management experience in a cross-functional environment.
Regulatory Affairs Certification (RAC) or equivalent professional certification.

Responsibilities

Develop and implement regulatory strategies for drug development and clinical trial submissions.
Prepare, review, and submit regulatory documents such as INDs, NDAs, BLAs, and amendments to the FDA and other regulatory agencies.
Coordinate with manufacturing, and quality teams to ensure compliance with regulatory requirements throughout product development.
Monitor changes in regulatory policies and guidelines and communicate their impact to internal stakeholders.
Manage interactions and negotiations with regulatory authorities to facilitate product approvals.
Maintain regulatory documentation and ensure timely responses to agency queries.
Provide training and regulatory guidance to project teams and senior management.