Manager, Regulatory Affairs

ADMA Biologics; Boca Raton, Northern (FL, KY); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

401K match

Medical & Dental insurance

Pet Insurance

Disability insurance

Paid holidays

PTO 3 weeks

Tuition assistance

Shuttle service

Job summary

ADMA Biologics seeks a skilled Manager, Regulatory Affairs to lead regulatory submissions and strategy for Boca Raton operations. The role involves coordinating INDs, BLAs, CTD documents, and lifecycle submissions, while guiding cross-functional teams and liaising with FDA and other regulators.

The position requires extensive regulatory experience across drug development, strong communication abilities, and a thorough understanding of GMP, GCP, and documentation practices.

Qualifications

• Minimum of 7 years of pharmaceutical regulatory expertise across drug development phases.
• Minimum of 5 years’ experience with Master’s degree.
• Experience preparing IND, BLA, CTD, and post-marketing submissions and risk assessments.

Responsibilities

• Coordinate regulatory submissions and maintain submission timelines.
• Determine regulatory strategy aligned with business goals and coordinate data collection across departments.
• Liaise with FDA, regulators, and contractors; guide cross-functional teams on regulatory requirements.
• Review and improve regulatory processes; ensure compliance with SOPs and policies.

Skills

Regulatory affairs

Regulatory strategy

Submission management

Project management

Cross-functional collaboration

Problem solving

Education

Bachelor’s degree in Pharmaceutical, Biological or Chemical Science

Advanced degree desirable

Tools

MS Office

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!

Job Title: Manager, Regulatory Affairs

Job Description:

Position Summary

This is an onsite, in-person position located in Boca Raton, Florida.

The Manager, Regulatory Affairs, supervises and participates in planning, preparing and evaluating regulatory documents for submission to governmental regulatory agencies like U.S. Food and Drug Administration. Serves as a liaison with regulatory agencies and contractors, as well as an informative regulatory resource for cross-functional teams. Ensures corporate policies and procedures comply with regulatory requirements.

Essential Functions (ES) and Responsibilities

• Provides accurate and timely regulatory guidance to all company functions while maintaining frequent contact with Associate Director of Regulatory Affairs.
• Responsible for preparation, review, presentation, and evaluation of all regulatory submissions. Assess accuracy and completeness of submission documents throughout product lifecycle, specifically pre-application submissions (e.g., meeting requests), new application submissions (e.g., Investigational New Drug applications [IND], Biological License Applications [BLA], Orphan Drug applications [OD]), maintenance submissions (e.g., end-of-phase reports, annual reports, changes to IND or BLA Common technical Document [CTD] dossier, safety reports, product license renewals, establishment license renewals, meeting requests) and post-marketing submissions (e.g., annual reports, periodic safety reports, annual reports of Post-marketing requirements or commitments), and other related documents or 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, and affiliates, and from contractors/vendors as needed. Liaises with partner companies as appropriate.
• 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. Advises senior regulatory management of challenges to achieving timely, accurate or complete submissions.
• 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, standard operatingprocedures (SOP) and work instructions (WI) that ensure efficient and compliant regulatory processes.
• Works closely with Quality Assurance to conduct regulatory risk assessments of quality system documents and practices. Utilizes problem solving skills to recommend risk mitigation strategies, and to develop alternative courses of action or contingency plans.

Education & Experience Requirements

Education Requirements: Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Advanced degree desirable.

Experience Requirements:

• Minimum of 7 years of practical pharmaceutical regulatory expertise across phases of drug development.
• Minimum of 5 years’ experience with 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.
• Must be able to represent ADMA Biologics with accuracy and sensitivity to regulatory issues.
• Detailed knowledge of laws and regulations, (specifically, US Federal Food, Drug and Cosmetic Act; Code of Federal Regulations; FDA guidelines), practices and international harmonization standards.
• Expert knowledge of Regulatory Affairs department SOPs.
• Must be able to balance multiple projects.
• Step-in to fill-in/take over ongoing projects with minimal notice.
• Multiple deadlines on conflicting projects with constant interruptions.

Compliance Requirements (ES)

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. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer

In addition to competitive compensation, we offer a comprehensive benefits package including :

• 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)
• Easily accessible to 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 www.dhs.gov/E-Verify .

ADMA Biologicsis an Equal Opportunity Employer.