Jazz Pharmaceuticals

US Lead Global Regulatory Strategy

Job Locations US-CA-Palo Alto
Posted Date 1 month ago(2/15/2018 9:07 AM)
Job ID
# of Openings
Research & Development


Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

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. 

Position Profile

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.

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.


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