Regulatory Affairs Manager
The Regulatory Affairs Manager is responsible for regulatory tasks, reporting and compliance and coordinating regulatory activities with the regulatory publisher and/or other vendors. This is currently the sole regulatory position within BERG – there is an opportunity for growth for an incumbent who is self-motivated and willing to take on new challenges.
- Manage Regulatory Affairs drug product development projects through entire lifecycle – from initiation through commercialization
- Review drug product labeling components for applicable Regulatory applications
- Compose or coordinate, review, and submit (assistance with vendor(s) as needed) to the FDA original INDs, NDAs, ANDAs, supplements, amendments, annual reports, and periodic adverse event reports in electronic CTD format.
- Coordinate with vendor electronic publishing of Regulatory submissions for submission to the FDA and other Regulatory authorities
- Serve as the Regulatory representative on cross-functional teams supporting products throughout the stages of development and commercialization.
- Ensure Regulatory and cross-functional project strategies and submission timelines are in alignment
- Develop and track Regulatory project timelines that incorporate submission requirements including CMC, clinical, and labeling functions
- Communicate Regulatory requirements and expectations to various contract organizations, including travel for on-site meetings as necessary
- Evaluate proposed changes to approved products for potential Regulatory impact and gather required data as needed to defend a Regulatory filing strategy
- Contact FDA and other Regulatory authorities for review status updates for pending applications and supplements.
- Author and review departmental SOPs that may impact Regulatory affairs
- Monitor various websites and publications to gather Regulatory intelligence on proposed product pipeline projects and any associated information.
- Build and manage departmental budget
- Perform due diligence audits of applications proposed for transfer from external partners. Review documentation submitted throughout the lifecycle of the application and request any additional information prior to authorization of the transfer.
- Perform timely compilation of materials for license renewals, updates and registrations
- Maintain Regulatory files/database and chronologies in good order. Establish and maintain a system for tracking changes in documents submitted to agencies or partners.
- Research Regulatory issues and disseminate Regulatory information to Production, QA, QC and R&D departments and senior management as required.
- Prepare regular update reports for CEO and senior management on regulatory projects/deliverables
- Plan, oversee, and monitor the work and professional development of direct reports
- Other duties as assigned
- S. in health, science or related field with four (4)+ years of applicable US Drug Regulatory Affairs experience; advanced degree preferred
- US Regulatory Affairs Professional Society Certification (RAC) is desirable
- Experience coordinating and filing electronic CTD submissions in the US
- Experience with Regulatory timeline development and document tracking
- Knowledge of FDA and international regulation, guidance, and standards applicable to company products
- Demonstrated leadership, excellent organizational skills and ability to work on a number of projects with tight timelines
- Communicates effectively with fellow employees, patients, contractors, and vendors
- A high degree of accuracy and attention to detail
- Strong interpersonal skills and an ability to build effective and constructive relationships
- Self-starter and ability to work independently
- Maintains confidentiality and security