Manager, Regulatory Affairs

Position Summary

The Manager, Regulatory Affairs is an onsite, in-person position located in Boca Raton, Florida. They supervise and participate in planning, preparing, and evaluating regulatory documents for submission to governmental regulatory agencies like the U.S. Food and Drug Administration. They serve as a liaison with regulatory agencies and contractors, and an informative regulatory resource for cross-functional teams. They ensure 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 the Associate Director of Regulatory Affairs.
• Responsible for preparation, review, presentation, and evaluation of all regulatory submissions.
• Affirms accuracy and completeness of submission documents throughout the 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 OPERATING PROCEDURES (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.

Benefits

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• 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 Biologics is an Equal Opportunity Employer.