Regulatory Affairs Manager jobs in West Palm Beach, FL

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 Senior Manager, Regulatory Affairs centrally located in Boca Raton, FL!

The Senior Manager, Regulatory Affairs supervises and participates in planning, preparing, and evaluating regulatory documents for submission to the U.S. Food and Drug Administration (FDA). Serves as a liaison with regulatory agencies and affiliates, as well as providing regulatory guidance to address FDA questions for both investigational and market product applications. Ensures corporate policies, procedures and manufacturing/testing activities comply with regulatory requirements and approved INDs/BLAs.

Qualifications

ESSENTIALS OF THE JOB:

• Provides accurate and timely regulatory guidance to Management, Process Development, Analytical Development, Manufacturing, and the Quality Assurance/Quality Control staff while maintaining frequent contact with the Head of Regulatory Affairs.
• Responsible for the preparation, review, presentation, and publishing of all FDA submissions to assure accuracy and completeness of submission documents, which includes but is not limited to meeting requests/briefing packages and presentations to the FDA (e.g., preIND/pre-BLA, end-of-phase II, Type A,B or C, and advisory committee meetings), Investigational New Drug Applications (INDs), Biologic License Applications (BLAs), Marketing and Promotional Materials, Product Listing and Establishment License Applications, and other related documents or CMC supplement submissions.
• Develops regulatory strategies, determines submission requirements, and requests necessary data, information, and documentation from pertinent departments and Subject Matter Experts (SMEs), as needed. Liaises with clients and Contract Manufacturing Organization (CMO) as appropriate.
• Assures supplements and amendments to INDs/BLAs are completed within specified regulatory timeframes. Reviews and approves all materials to be included in submissions for accuracy and completeness, which include stability, validation and investigation reports, product testing data and information packages prepared by SMEs.
• Acts as an authorized official for the organization and corresponds with regulatory agencies as necessary to discuss regulatory strategies and request FDA guidance. Participates and provides regulatory support during audits and FDA inspections, as necessary.
• Responsible for providing regulatory guidance regarding investigational and marketed products and provides regulatory support as needed to clients and CMOs.
• Oversees regulatory operations by tracking submissions and Post Marketing Requirements/Commitments. Maintains investigational and marketing applications and SOPs. Appropriate knowledge of eCTD format and submission software systems.
• Advises Management of any potential regulatory risks and/or delays in submissions for investigational and marketed products.
• Participates in company projects, project-based tasks and/or special projects as assigned by the Head of Regulatory Affairs.
• Reviews and evaluates change controls and deviations to determine regulatory impact and reporting requirements. Evaluates, prepares, and submits Biological Product Deviation Reports, as necessary.
• Advises Project Teams regarding regulatory requirements; serves as Project Team member to ensure primary and alternate strategies are appropriately explored.
• Serves in advisory roles to project teams regarding regulatory requirements and strategy development; keeps management and team members abreast of project status and adherence to project deadlines.
• Ensures corporate policies and procedures are in full compliance with regulatory obligations.
• Serves as liaison with the FDA, company personnel, corporate partners, and other regulatory agencies to ensure regulatory activities are completed accordingly within the required timelines.

Education Requirements:

Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Master’s degree preferred.

Experience Requirements: 

A minimum of ten years of pharmaceutical regulatory experience including at a management level in Regulatory Affairs with an emphasis on Biologics and BLA submission experience.

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
 
Just awarded 2023 Best Places to Work!

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.