Senior Manager, Regulatory Strategy
Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases – often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.
We are looking for the best and brightest talent to join our team. If you’re looking to be a part of a company with an unwavering commitment to improving patients’ lives and being a great place to work, we hope you’ll explore our career openings and get to know Jazz Pharmaceuticals.
The Senior Manager, Regulatory Strategy will be responsible for supporting product applications of all types within commercial and development projects. A Senior Manager Regulatory Affairs will be a key member of project teams and teams responsible for evaluation of product concepts.
Essential Job Functions:
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 and coordinate regulatory information as a team member, covering CMC, clinical, labeling, and post-approval change activities
• Provide in-depth reviews of protocols, reports, presentations, and other documents
• 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 submission plans and 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
• Manage regulatory data and information within systems
- Bachelor’s degree required; scientific discipline preferred. Advanced degree is also preferred.
- Minimum of 4 to 5 years of regulatory strategy experience with increasing responsibility
- Demonstrated understanding and strategic application of regulations and guidelines for drug development at IND and NDA/BLA stages
- Excellent verbal and written communication skills
- Leadership ability within a multiple time zone team environment
- Ability to work with limited supervision, to set priorities to meet timelines and to motivate and influence others
- Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators
- Some travel will 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.
Learn more here
Job posted: 2021-06-08