Position Summary:

The Senior Manager, Regulatory Affairs, supervises and participates in the planning, preparing, and interpreting 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.

Essential Functions and Responsibilities:

• 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), Orphan Drug Applications, 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. Liaises with clients and Contract Manufacturing Organization (CMO) as appropriate.
•  Provides signatory approval for supplements and amendments to INDs/BLAs, assuring submissions are completed within specified regulatory time limits. 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.
• Act 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.
•  Responsible for providing regulatory guidance regarding investigational and marketed products and provide regulatory support as needed to clients and affiliates.
• Oversee Regulatory Operations by tracking submissions, Post Marketing requirements/commitments, maintenance of investigational and marketing applications and SOPs (standard operating procedures). Appropriate knowledge of eCTD format and submission software systems. 

Competencies

Additional Essential Functions and Responsibilities:

• 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 Critical Deviations to determine regulatory impact and reporting requirements. Evaluates, prepares, and submits Biological Product Deviation Report, as necessary.
• Advises Project Teams regarding regulatory requirements; serve 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; keep 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 and Experience Requirements:

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

Experience Requirements:   Ten plus years plus of practical pharmaceutical development regulatory experience at a management level in Regulatory Affairs with an emphasis on Biologics and BLA submission experience.

Compliance Requirements:

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, accurate documentation of sales interactions, 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.