Manager, Regulatory Affairs

ADMA BioCenters; Boca Raton (FL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401K plan with employer match and immediate vesting

Medical, Vision, Life and Dental Insurance

Tuition assistance

Job summary

ADMA BioCenters in Boca Raton, Florida, is looking for a Manager, Regulatory Affairs to oversee regulatory submissions and ensure compliance with FDA regulations. The ideal candidate should have over 7 years of experience in pharmaceutical regulatory affairs and a relevant Bachelor’s degree.

This role requires effective communication skills and the ability to manage multiple projects. Benefits include a 401K plan, insurance, and paid time off.

Qualifications

• Minimum of 7 years of practical pharmaceutical regulatory experience.
• Minimum of 5 years of experience with a Master’s degree.

Responsibilities

• Provide accurate regulatory guidance to all company functions.
• Prepare, review and evaluate regulatory submissions across the product lifecycle.
• Determine regulatory strategy to align with business strategy.

Skills

Effective written and verbal communication

Collaboration

Problem-solving

Negotiation skills

Education

Bachelor’s degree in Pharmaceutical, Biological or Chemical Science

Advanced degree desirable

Tools

Office software applications

Job description

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands‑on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Manager, Regulatory Affairs in Boca Raton, Florida.

Position Summary

The Manager, Regulatory Affairs supervises and participates in planning, preparing, and evaluating regulatory documents for submission to governmental regulatory agencies such as the U.S. Food and Drug Administration. They serve as a liaison with regulatory agencies and contractors, and as an informative regulatory resource for cross‑functional teams. They ensure corporate policies and procedures comply with regulatory requirements.

Essential Functions and Responsibilities

• Provides accurate and timely regulatory guidance to all company functions while maintaining frequent contact with the Associate Director of Regulatory Affairs.
• Responsible for preparation, review, presentation, and evaluation of all regulatory submissions across the product lifecycle, including pre‑application, new application, maintenance, and post‑marketing submissions.
• Determines regulatory strategy that aligns with business strategy, defines submission requirements, and coordinates the collection of required data, information, and documentation from pertinent departments, facilities, affiliates, and contractors/vendors.
• Plans regulatory milestones, sets timelines, and assures timely, accurate, and complete submissions to regulatory agencies. Provides signatory approval for reports and amendments or supplements to INDs or BLAs and advises senior regulatory management of challenges.
• Oversees regulatory operations by developing or maintaining project timelines, milestones, submission tracking systems, and document archive systems. Practices regulatory process improvement by reviewing, writing, and revising policies, SOPs and WIs.
• Works closely with Quality Assurance to conduct regulatory risk assessments of quality system documents and practices, and recommends risk mitigation strategies and contingency plans.

Education & Experience Requirements

• Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Advanced degree desirable.
• Minimum of 7 years of practical pharmaceutical regulatory experience across phases of drug development.
• Minimum of 5 years of experience with a Master’s degree.

Preferred Experience

• Effective written and verbal communication, collaboration, problem‑solving, and negotiation skills.
• General knowledge of Good Manufacturing Practices, Good Clinical Practices, Good Documentation Practices, and Good Laboratory Practices.
• Excellent program management skills.
• Proficient in common office software applications.
• Ability to represent ADMA Biologics with accuracy and sensitivity to regulatory issues.
• Detailed knowledge of U.S. Federal Food, Drug and Cosmetic Act, Code of Federal Regulations, FDA guidelines, and international harmonization standards.
• Expert knowledge of Regulatory Affairs department SOPs.
• Ability to balance multiple projects and step in to fill‑in or take over ongoing projects with minimal notice.
• Manage multiple deadlines on conflicting projects with constant interruptions.

Compliance Requirements

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training and adherence to data privacy regulations. The role requires proactive participation in compliance reviews, prompt reporting of potential issues, and ongoing education to stay updated on relevant FDA regulations.

Benefits

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company paid holidays
• 3 weeks paid time off (within the first year)
• Tuition assistance (after the first year)
• Convenient location near Tri‑Rail; free shuttle to the Boca Tri‑Rail station

ADMA Biologics uses E‑Verify to confirm the employment eligibility of all newly hired employees. To learn more about E‑Verify, including your rights and responsibilities, please visit the Department of Homeland Security website.

ADMA Biologics is an Equal Opportunity Employer.