Our client is a commercial-stage biopharmaceutical company focused on the discovery and development of targeted therapeutics for the treatment of rare neuromuscular diseases. They are seeking a Regulatory Strategy Leader to formulate and lead implementation of regulatory strategies for their new gene therapy programs which will be starting first-in-human trials this year. This is a high profile position where you can make a big impact on the company and also on patients’ lives.
- Develop regulatory strategies that provide a streamlined development and approval timeline for pre-clinical gene therapy programs
- Guide project teams to implement appropriate regulatory strategies.
- Represent the company at FDA and EMA agencies for all assigned products. Oversee the planning and conduct of meetings with regulatory agencies as appropriate.
- Plan and manage integration of multidisciplinary regulatory programs into the project team development plans for all assigned projects.
- Initiate and respond to regulatory agency contacts to assure expedient and efficient review and approval of products.
- Accurately interpret regulatory guidelines and advise senior management on any proposed regulatory, scientific, and pertinent legal issues.
- Ensure that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well-organized, accurate, high quality and are in regulatory compliance.
- Supervise and coordinate all regulatory activities required for submissions to regulatory agencies for assigned products.
Knowledge and Skills:
- Bachelor’s degree in a scientific field. MS/PhD preferred but not required.
- 7+ years of regulatory affairs experience within the biopharmaceutical industry with development experience.
- Regulatory affairs experience with biologic programs is required. Experience with gene therapy a plus.
- Knowledgeable in ICH, FDA, and EMA regulations/guidelines required
- Demonstrated knowledge of drug development process is essential.
- Must have prior experience working with the FDA and EMA.
- Experience working on a successful NDA and/or BLA.
- Strong communication and interpersonal skills.