Jazz Pharmaceuticals is seeking a Senior Manager in Regulatory Affairs to join the Global Regulatory Strategy team. The Senior Manager will support the Global Regulatory Lead for a hematology/ oncology product. The Senior Manager will be responsible for ensuring regulatory activities needed to maintain registration in the US are complete, support EU/ ROW registration activities and fulfill regulatory activities required for global clinical trials and support for ongoing development activities for the product.
Experience and Education:
- Minimum 5 years’ experience in Regulatory Affairs, including experience managing regulatory aspects of an IND and global clinical trial activities.
- BS or BA degree
Candidate must have:
- Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA stages.
- Solid understanding of and experience with electronic Common Technical
- Document (eCTD) submissions with ability to create content.
- Excellent written and verbal communication skills
- Ability to work effectively in cross functional teams
- Excellent organizational and time management skills, ability to manage multiple complex projects
- Travel up to 10%-20% of the time
Roles and Responsibilities
- 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.
- Represent US regulatory affairs on global regulatory subteam, providing updates on US specific activities and any changes to guidelines that could impact development program.
- Support Global Regulatory Lead for the molecule in developing strategies for new development projects and partnerships, as needed.
- Identify and communicate potential risks associated with regulatory strategies.
- Represent Regulatory Affairs as a team member, covering clinical and general regulatory activities.
- Provide in-depth review of protocols, reports, presentations and other documents.
- Document regulatory activities with FDA and other Health Authorities
- Prepare IND and NDA submissions including clinical trial applications, amendments, periodic safety updates, supplements, meeting requests, briefing packages, annual reports, etc. Assist in managing internal review and submission of these items.
- Ensure consistent, completeness and accuracy or adherence to regulations and applicable guidelines for all regulatory submissions.