Senior Manager, Regulatory Affairs
Location: Onsite in Ft. Lauderdale, Florida
Company Profile: Biopharmaceutical company with (3) commercial products for infectious diseases.
What you can expect to be doing…
- Supervise and participate in planning, preparing and evaluating regulatory documents for submission to the U.S. Food and Drug Administration (FDA).
- Serve 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.
- Ensure corporate policies, procedures and manufacturing/testing activities comply with regulatory requirements and approved INDs/BLAs.
- Provide 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.
- Prepare, review, present, and publish 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.
- Develop regulatory strategies, determine submission requirements and requests necessary data, information, and documentation from pertinent departments and Subject Matter Experts (SMEs), as needed. Liaise with clients and Contract Manufacturing Organization (CMO) as appropriate.
- Assure supplements and amendments to INDs/BLAs are completed within specified regulatory timeframes.
- Review and approve 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.
- Acs as an authorized official for the organization and correspond with regulatory agencies as necessary to discuss regulatory strategies and request FDA guidance.
- Participate and provide regulatory support during audits and FDA inspections as necessary.
- Provide regulatory guidance regarding investigational and marketed products and provide regulatory support as needed to clients and CMOs.
- Oversee 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.
- Serve as liaison with the FDA, company personnel, corporate partners and other regulatory agencies to ensure regulatory activities are completed accordingly within the required timelines.
What you will bring to the table:
Bachelor’s degree in Pharmaceutical, Biological or Chemical Science or related field. Master’s degree preferred.
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.
Please email MichelleL@ScientificSearch.com to learn more about this exciting opportunity!
Reference Job# 18183