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Manager, Regulatory Affairs

Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: January 18, 2020

Job Description:

OVERVIEW

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

Essential Functions

* Participate as an active member of a multi-disciplinary team to establish development and regulatory strategies for commercial products and late stage and early development programs. 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 consistency, completeness, accuracy and adherence to regulations and applicable guidelines for all regulatory submissions

Required Knowledge, Skills, and Abilities

* Five years of regulatory experience

* 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

Required/Preferred Education and Licenses

* BS/BA with a minimum of five years of regulatory experience

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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Keywords: Jazz Pharmaceuticals, San Francisco , Manager, Regulatory Affairs, Executive , Palo Alto, California

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