Job Description
Provides regulatory expertise and support for pre-clinical, clinical, and commercial areas for investigational and marketed products. Ensures development of drugs are in accordance with global regulations in order to approve drugs quickly and smoothly within typical approval timeframes.
- Ensures marketed products are supported with minimal questions and issues from the regulatory agencies. Works with Regulatory Management to establish well defined regulatory pathways and creates accurate and timely documents for IND and NDA submission and final approval.
- Under the direction of the Senior Director or VP Regulatory Affairs provides strategic regulatory leadership and guidance to the project teams.
- Designs programs for complete and accurate IND/CTA submissions and ensures that clinical trials are designed to meet regulatory requirements.
- Defines regulatory expectations for teams, identifies elements of INDs, and FDA requirements (and other Health Authorities in collaboration with regional regulatory affairs for CTAs), develops positions for responses to regulatory agencies, defines strategy for negotiations and formal document submission, and provides strategic input in the development of the plan.
- Interacts with regulatory agencies and ensures conversations and communications are focused, amicable and documented.
- Oversees the submission of product registration of new drugs, progress reports, supplements, amendments, and periodic adverse experience reports. Develops strategies, drafts responses, and/or reviews responses and documents intended for submission to FDA or other health authorities to assure compliance with regulatory standards.
- Oversee the review of documents/reports generated by RA support staff or contractors or other project team members to assess the likelihood that the content will meet pre-specified objectives, and provides input towards this end. Prepares submissions to health authorities working with Regulatory Operations and support staff.
- May serve as part of Global Product Development Committee, monitoring the products with the affiliates as well as co-licensing partners Member or Co-Chair of the Clinical - Regulatory Sub team
- Trains, and coaches staff; evaluates employee performance on an ongoing basis for direct (if any) or indirect reports, and completes annual performance reviews as appropriate.
- Supports or leads non-project activities e.g. SOP/standards development, organizational initiatives, etc.
Knowledge:
- Comprehensive knowledge of the drug development process, drug laws, globalregulations, and guidelines.
- Good understanding of the global regulatory agencies.
- Proven success of submitted sNDA, IND and NDA.
Skills:
- Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word,Excel, PowerPoint, and Outlook).
- Strong analytical skills and problem solving ability.
- Strong communication and presentation skills.
- Knows how/when to apply organizational policy or procedures to a variety of situations.
Education and Related Experience:
- Bachelor's degree with 6 years experience in regulatory affairs or related areas (e.g. clinical development, project management, quality assurance, etc.) in pharmaceutical or healthcare related industry. Direct or indirect supervisory and medical device experience a plus.
- Experience with FDA, other health authority, or project meetings/ interactions desirable.
- Travel (approximately 20%)