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 an 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 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.
- Determine 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.
- Plan regulatory milestones, set timelines and assure timely, accurate and complete submissions to regulatory agencies. Provide signatory approval for reports and amendments or supplements to INDs or BLAs. Advise senior regulatory management of challenges to achieving timely, accurate or complete submissions.
- Oversee Regulatory Operations by developing or maintaining project timelines/milestones/submission tracking systems, and document archive systems. Practice regulatory process improvement by reviewing, writing and revising policies, standard operating procedures (SOP) and work instructions (WI) that ensure efficient and compliant regulatory processes.
What you will bring to the table:
- Minimum of 7 years of practical pharmaceutical regulatory expertise across phases of drug development. Minimum of 5 years experience with Master’s degree. Experience in Biologics and BLA submission is preferred.
Reference Job# 18183