Associate Director, Regulatory Affairs

Summary

To manage and assist with regulatory filings to support Client's business. Primarily responsible for the regulatory compliance of the Plasma Services Organization. Acts as the designated company authorized official for all communications with regulatory agencies regarding Plasma Collection related topics. Supervises and participates in planning, preparing and evaluating regulatory documents for submission to the U.S. Food and Drug Administration (FDA). This position provides advice and direction regarding regulatory requirements for source plasma collection in the US and other locations as required.

Duties

• Be a versatile regulatory affairs department team member and produce work-product commensurate with professionalism and of the highest quality standards to submit to regulatory authorities for review and approvals.
• Provides regulatory affairs guidance and support to Plasma Operations, Center Management, and Plasma Corporate staff to ensure regulatory compliance by Center facilities and Plasma organization.
• Reviews and interprets all applicable regulations governing Plasma processes and procedures to ensure full compliance.
• Ensures Plasma Centers are in compliance with all applicable governing regulatory agencies, assists with documentation for inspections and audits, provides insight and guidance for regulatory reporting and follow up of any 483’s or other identified issues; recommend corrective and preventive actions as necessary.
• Is available to regulatory authorities during inspections to ensure appropriate information is supplied as requested. Accompanies FDA inspectors for pre-scheduled new and routine center audits as directed.
• Prepares submission of Biologics License Applications (BLA's) associated to center establishments and plasma products and CLIA/COLA licensing as related to Plasma Center operations as directed.
• Prepares FDA Annual Report as it relates to the Plasma collection organization.
• Assists and collaborates with Plasma QA and Plasma Operations in the crafting audit and inspection responses.
• Provides regulatory affairs related consultation regarding Lookback, Post-Donation and Error/Accident, and BPDR situations as requested.
• Works with Plasma QA to notify FDA of any recalls and follows up with the FDA, other applicable regulatory agencies and customers as required, in accordance with the regulations and applicable laws.
• Aids in review from a regulatory affairs standpoint, of new and revised Plasma Center Standard Operating Procedures (SOP's), and review of related training materials with regard to applicable regulations to ensure compliance with applicable laws.
• Makes regulatory decisions and recommendations as applicable and required in collaboration with Regulatory Affairs and appropriate company leadership and other departments.
• Responsible for the preparation, review, presentation, and publishing of 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, 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 as directed to support the company.
• Develops regulatory strategies, determines submission requirements and requests necessary data, information, and documentation from pertinent departments and Subject Matter Experts (SMEs), as needed.
• Assures supplements and amendments to BLAs are completed within specified regulatory timeframes. Reviews all materials to be included in submissions for accuracy and completeness, which include collection data, viral marker data, stability, validation and investigation reports, product and plasma unit testing data and information packages prepared by SMEs.
• Oversees regulatory operations by tracking submissions and Post Marketing Requirements/Commitments. Appropriate knowledge of eCTD format and submission software systems.
• 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 plasma collection project teams (or others as directed) regarding regulatory requirements and strategy development; keeps management and team members abreast of regulatory affairs related project status and adherence to project deadlines.
• Participates in company projects, project-based tasks and/or special projects as assigned by the Senior Director, Regulatory Affairs.
• Additional duties related to supporting the needs of the business can be assigned by senior management as deemed necessary.
• This position is 50% on site with a 50% travel component to plasma sites in the SE USA.
  
  

Requirements

• 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 in Plasma industry or related field with an emphasis on Biologics and BLA submission experience.
• As a part of our Quality Systems and cGMP initiatives, employees are responsible for ensuring compliance with all Client Quality policies, standards and SOPs in their area of work and responsibility. This includes ensuring all Quality Assurance (QA) records and reports, Human Resources (HR) policies, and Environmental Health and Safety (EH&S) procedures and practices are completed in a timely manner. Any delay or failure to comply with policies, standards and procedures is required to be communicated/escalated to the appropriate responsible parties, such as QA, HR, or EH&S depending on the issue.
• Strong technical background. Knowledge of U.S. and other regulations (FDA, GHA, EMA, cGMP, OSHA, CLIA/COLA, etc.), industry initiatives (IQPP), and Plasma Center Standard Operating Procedures (SOPs).
• Effective written and verbal communication skills.
• General knowledge of pharmaceutical development and federal regulations in pharmaceutical principles of document management.
• Excellent program management skills. Proficient in word processing packages.
• Must be able to represent the company with accuracy and sensitivity to regulatory issues.
• Detailed knowledge of: Federal Food, Drug and Cosmetic Act; Code of Federal Regulations; FDA guidelines; and Regulatory Affairs department SOPs.