Senior Manager, Regulatory Strategy

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Job Description

Brief Description:
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.

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.

Minimum Requirements:

• Bachelor's degree required; scientific discipline. Advanced degree is also preferred. 
• Experience in Oncology within a biotech/pharma company.
• 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.

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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.

FOR US BASED CANDIDATES ONLY
 

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the