24 days ago
This position is responsible for the preparation of and assures all relevant CMC requirements are met for regulatory submissions (including IND, BLA, CTA, etc.) to the FDA and other Regulatory Agencies. Facilitates the development, implementation and maintenance of Regulatory Affairs systems. Manages the activities of direct reports.
- Oversees and coordinates the preparation of documentation packages for regulatory submissions (including IND, BLA, CTA, etc.) to the FDA, and other Regulatory Agencies, which also includes submissions required to agencies regarding genetically modified organisms (GMO).
- Review, coordinate and approve CMC regulatory documentation for inclusion in INDs, NDAs, BLAs and worldwide submissions and compile all documentation and submit to FDA and foreign regulatory agencies.
- Works to further develop infrastructure for Regulatory Operations regarding documentation preparation and electronic submissions
- Develops and maintains current regulatory knowledge and keeps up with/implements the changes required for regulatory compliance
- Maintains regulatory documentation including submissions to and correspondence with each governing authority
- Coordinates collection of information from other departments (CMC, Quality Assurance, Clinical Operations, and Operations, etc.) for incorporation into regulatory submissions including any expedited reporting.
- Reviews CMC and technical documentation for regulatory compliance
- Performs other appropriate administrative duties, such as preparing correspondence and filing, where necessary
- Manage resources for submission preparation and communication with internal/external customers to achieve all phases of product approval and commercialization of products.
- Participate in project teams to manage activities and/or changes related to product development, manufacturing, and commercialization. Provide review of and input to development plans. When appropriate, provide guidance for problems being discussed and recommend solutions.
- Assists in the evaluation of deviation, change control and product incident documents for impact on submissions and filing requirements.
- Reviews all promotional labeling and advertising for clinical trial and commercial labeling.
- Manage external regulatory consultants and project deadlines for ex-US countries.
- Reporting of clinical events as required to regulatory authorities.
- Maintain current knowledge of FDA and international regulations and guidance related to clinical trials.
- Knowledge of EU and rest of world (ROW) clinical trial application requirements.
- Responsible for maintenance of regulatory affairs product files to support compliance.
- Review SOPs and protocols with regard to regulatory matters.
- Provide mentoring to current staff and have skill sets for directly managing staff.
- B.A or B.S. degree in an appropriate scientific field - 10-15 years’ experience in Pharmaceutical/Biotech Industry
Experience and skill requirements:
- Gene Therapy (AAV) experience Desired and/or Biologics experience.
- Knowledge and practical understanding of ICH Guidelines regarding GMP/GCP, ICH Guidelines for CTD/eCTD, and CBER requirements for the drug approval process
- Previous participation in preparing regulatory submissions (IND, BLA, CTA, etc.) to the FDA and EU Regulatory Authorities
- Solid understanding of the e-CTD specifications for electronic submissions
- Strong abilities in technical writing and documentation preparation/publishing using Adobe Acrobat
- MS Office Expertise: Outlook, Word, Excel, PowerPoint, Project, Visio
- Strong interpersonal, organizational, and time management skills
- Ability to handle matters of strict confidentiality and sensitivity
- Appropriate GXP training
- Excellent verbal and written communication skills