The Manager, Regulatory Strategy will be responsible for registration and regulatory support of US commercial and development projects.
Job Responsibilities and Requirements:
- Participate as an active member of a multi-disciplinary team to establish development and regulatory strategies for commercial products, late stage, and early stage development programs. Identify and communicate potential risks associated with strategy scenarios
- Represent Regulatory as a team member, covering CMC, clinical, labeling, and post-approval change activities
- Provide in-depth reviews of protocols, reports, presentations, press releases, and documents
- Serve as a primary contact with the FDA; document regulatory contacts with health authorities.
- Prepare IND, NDA, and BLA submissions including original marketing applications, clinical trial applications, amendments, supplements, variations, responses to Agency questions and requests, meeting requests, briefing packages, annual reports, periodic safety reports, etc. Help manage the internal review and submission of these items.
- Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for all regulatory submissions
- Manage timelines to ensure approvals are timely and development objectives are met
- Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies
- Provide risk assessments and recommendations for various regulatory scenarios
- Participate in the electronic review and quality verification of regulatory submissions
- BS/BA with a minimum of two to five years of regulatory experience; Experience supporting the preparation and filing of a U.S. marketing application (NDA or BLA) is required.
- Strong English language written and verbal communication skills
- Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages
- Solid understanding of and experience with electronic Common Technical Document (eCTD) submissions with ability to create content
- Leadership ability within a team environment
- Ability to work independently; willingness to voice opinions in the group environment
- Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
- Some travel may be required
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.