Chief Civil Structural Engineer

The Senior Director, Regulatory Affairs and Quality will report to the President & CEO, and will be responsible for reviewing and approving established labeling documents (pre- and post-approval products), ensuring the preparation of high-quality prescription labeling documents, filed under an NDA/ANDA/510K, providing strategic input into the review and approval of effective yet FDA compliant clinical development, commercial (advertising and promotion) campaigns and commercialization activities, CMC, quality and pharmacovigilance matters as it relates to regulatory matters and filings, while adhering to federal regulations and meeting deadlines driven by company goals. Responsible for all correspondence with FDA and submitting all regulatory documents to FDA.

Regulatory

• Responsible for assuring that projects are assigned to internal or external team members to meet departmental goals, FDA timelines, and to ensure the team adequately functions to meet all company objectives.
  
• Perform in-depth reviews and approvals of labeling and submission documents, for quality, content, and accuracy, prior to final disposition.
  
• Hands-on leader in regard to daily workload; in addition to managerial responsibilities, this position could have independent work assignments to manage on behalf of the team, if needed.
  
• Provide leadership in the preparation of all NDA submission documents including handling clinical, CMC, labeling, PADER, supplements, annual reports and 510Ks.
  
• Establish/maintain a tracking database to capture all assigned pre- and post-approval labeling projects.
  
• Work to ensure submissions are reviewed and transmitted to FDA on time while following the Electronic Common Technical Document (eCTD) requirements.
  
• Prepare responses to FDA deficiencies pertaining to submissions, as necessary.
  
• Prepare citizens petitions and controlled correspondence with FDA, as necessary.
  
• Prepare annual PDUFA information requests and facilitate payments.
  
• Act as liaison with Office of Prescription Drug Promotion (OPDP) for assigned marketed products to facilitate the FDA review of advertising and promotional materials (e.g. launch materials submitted for advisory).
  
• Ensure a highly effective and efficient review and approval process for advertising and promotion materials and the timely and accurate submission of branded materials to OPDP in compliance with FDA regulations.
  
• Attend project meetings to ensure labeling timelines are met and provide labeling updates to the project team for those products being discussed.
  
• Provide guidance and leadership with regard to best practices in the labeling arena.
  
• Maintain a metric of all team projects for reporting purposes.
  
• Create, train, and/or revise Standard Operating Procedures (SOPs), as appropriate.
  
• Maintain knowledge of regulations, guidelines, and SOPS applicable to all areas of clinical development, IND/NDA submissions, iPSP, post marketing commitments and labeling discussions.
  
• Participate in continuous improvement efforts related to business practices and tools utilized within the role.
  
• Review & submit Annual Reports/Periodic Safety Update Reports for all the approved products.
  
• Prepare and submit labeling supplements for approved products.
  
• Review and approve various CMOs change requests.
  
• Review Structured Product Labeling (SPL) for team projects to ensure product data elements align with the required drug listing regulations.
  
• Ensure established SPL is submitted through FDA s Electronic Submission Gateway, upon application approval, for timely posting to DailyMed in order to meet launch readiness, maintain current labeling content on DailyMed, and FDA NDC directories.
  
• Updates to CMC and Labeling databases.
  
• Responsible for archival of the electronic submission documents in the product-specific files.
  
• Prepare the eCTD compilation of NDAs, 510Ks and other supplements (PAS, CBE-30, CBE).
  
• Responsible for the maintenance of Establishment Registration for all facilities.
  

Quality

• Host inspections by FDA and other regulatory authorities as necessary.
  
• Prepare, review and update Standard Operating Procedures (SOPs) pertaining to Quality.
  
• Interact and follow-up with the manufacturer/business vendors/distributors for maintenance and update quality agreements.
  
• Handle quality complaints, active follow-up with the patient/reporter for follow-up questions, batch details, making arrangements to procure complaint samples from the complainant and forwarding to the QA team and active follow-up calls with reporters to share the investigation details.
  
• Active follow-up with the finance/operations department to ensure timely restitution/credit to the wholesaler/distributor.
  
• Coordinate medical information inquiries through local service providers.
  
• Support supply chain teams for investigation of temperature excursion of product shipments
  
• Review of change controls and batch manufacturing, testing and packaging records with the supervision of senior CMC member.
  
• Perform release of each batch of Company-owned products and review release documents for products which Company serves as own-label distributor.
  

Pharmacovigilance Responsibilities

• Assist in third-party processing of adverse events and sharing with the safety team and quality team.
  
• Active follow-up with the patient/reporter/physician for follow-up questions, batch details, seeking consent from the patient to reach the physician etc.
  
• Active follow-up with the safety team and quality team from a safety and quality standpoint and ensuring completion of investigation
  
• Monitoring and review of consolidated monthly 15-day reports and PADERs.
  
• Monitoring late case reporting events with the safety team and ensuring timely and effective CAPAs.
  
• Preparation, review and updating SOPs pertaining to Pharmacovigilance.
  
• Interaction and follow-up with business vendors/distributors and local service providers for maintenance and updating safety data exchange agreements.
  
• Audit of local service providers/safety reporting partners.
  
• Handle queries from Agency s MedWatch/DQRS in a timely manner.
  
• Maintaining and monitoring pharmacovigilance schedule, updated package inserts, launch dates of the approved products.
  
• Coordination, collection and sharing of post-approval documents with local service providers and safety reporting partners.
  
• Reconciliation activities of adverse events and product complaints.
  
• Hosting Pharmacovigilance audits/inspections.
  

• Bachelors in Pharmaceutical Sciences, Masters preferred
  
• 12-15 years of experience in regulatory, quality, and pharmacovigilance environment in pharmaceutical and/or medical device industry
  
• Regulatory Affairs Certificate is a plus
  
• Ability to handle multiple projects, motivated to grow in a fast-paced working environment
  
• Must be proficient in applicable computer and database applications including MS Word, MS Excel, PowerPoint and Adobe Acrobat Professional (PDF).
  
• Must be well organized, detail-oriented, have the ability to multi-task and manage changing priorities.
  
• Demonstrable applicable knowledge in FDA regulations and FDA guidelines are also required.
  
• Demonstrable skills in oral and written communications, independent judgement, problem-solving and effective managing and adhering to timelines.