Regulatory Affairs Manager in Largo, Florida at Eagle Labs, Inc

About Company:

At Eagle Labs Inc., we’re proud to be at the heart of American manufacturing—where precision, innovation, and people come together to build the future. For over 24 years, we’ve been producing high-quality Nutritional Supplement and Skin Care product with a commitment to excellence that sets us apart.

But what truly makes Eagle Labs a great place to work isn’t just what we make—it’s how we make it, and who we make it with.

We believe a strong company starts with a strong team. That’s why we’ve built a workplace culture grounded in respect, safety, growth, and opportunity.

What sets us apart as an employer:

• Skilled craftsmanship meets modern innovation
  Our employees work with the latest tools, technologies, and lean manufacturing processes to deliver products we’re proud of. People-first culture
  We offer competitive pay, great benefits, ongoing training, and a strong focus on health, safety, and work-life balance.

• Opportunities to grow
  Whether you're just starting out or bringing years of experience, we provide clear pathways for advancement, apprenticeships, and leadership development.

• Teamwork and pride
  At Eagle Labs, you’re not just doing a job—you’re contributing to something bigger. We value the pride that comes with building something with your hands and your team.

Eagle Labs Inc. is more than a workplace. It’s a place where hard work is rewarded, careers are built, and every employee is valued. Join us—and help shape the future of manufacturing.

About the Role:

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.

Minimum Qualifications:

• 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.

Preferred Qualifications:

• 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.

Skills:

The Regulatory Affairs Manager utilizes their expertise in regulatory affairs daily to develop compliant strategies that align with regulatory objectives for Suppliments. Their knowledge of regulatory submissions ensures that all documentation meets stringent agency requirements, facilitating smooth review processes. Skills in biotechnology and pharmaceutical industry standards enable them to interpret complex scientific data and translate it into regulatory language. Effective communication and negotiation skills are essential for managing interactions with regulatory bodies and internal teams. Additionally, project management and analytical skills help in coordinating multiple submissions and maintaining up-to-date regulatory intelligence to anticipate and address compliance challenges proactively.