at Jazz Pharmaceuticals in Austin, Texas, United States
Job Description
If you are a Jazz employee please apply via the Internal Career site
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical 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 and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
This Job Description provides a summary of the duties and/or characteristic of work performed and is not inclusive of every detail of the job for every individual assigned to the position. This description will be reviewed periodically and revised as duties and responsibilities change with business demands. Other duties not listed above may be assigned as needed.
Brief Description:
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. Our focus is on CNS/sleep, hematology/oncology and other areas in which our unique approach may be able to address significant treatment gaps. The Senior Director, and Global Regulatory Lead (GRL) will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for Lead Indication(s) for a Novel Oncology Investigational Product. The GRL will be responsible for regulatory aspects related to product development and approval, in alignment with the global business strategy and in partnership with the functional subject matter experts within GRADS and across Jazz. This position will play a major role in shaping cohesive regulatory strategy for assigned program(s) and ensuring effective integration of broad regulatory ideas/tactics supporting program strategy. Leads the development of US and international regulatory strategy for assigned projects/regions. Addresses complex issues, providing innovative regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams, GRADS functional team and GRADS leadership. Skill in adeptly creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development, and in leading productive health authority interactions, including well organized preparation of cross functional teams. Supervises direct reports in execution of regulatory strategy and works closely with other indication/asset leads across the organization.
Essential Functions/Responsibilities
As Senior Director, Oncology:
Represents Global Regulatory Affairs and Drug Safety (GRADS) as a member of the cross functional teams and governance committees. Responsible for ensuring collaboration with key internal stakeholders across various functions to ensure successful planning and execution of the global regulatory strategy for assigned program(s).
Oversight, mentoring and development of Oncology Regulatory Affairs strategists
Accountable for the development and maintenance of a global regulatory strategy plan. In conjunction with GRT/regulatory strategists, ensure that relevant input is vetted and included in the regulatory strategy in order to deliver on the Target Product Profile (TPP), regional specific needs, regulatory environment, regulatory risks and mitigations, and global submission strategies.
Identify and assess regulatory risks associated with product development and recommend strategies to mitigate risks.
Ensure appropriate representation ofregulatory affairs on key internal program/project teams.Ensure strategic regulatory input is provided to key development activities and documents, including clinical protocols, clinical and nonclinical reports and summary documents, statistical analysis plans, etc. Leverage GRT as appropriate to ensure appropriate input is provided throughout the development process.
Lead Global Regulatory team for assigned molecule(s):
Facilitate exceptional regulatory team performance by leading regulatory team meetings... For full info follow application link.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, s ex, national origin, disability status, protected veteran status, or any characteristic protected by law.
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Job Posting:
2958675
Posted On:
Nov 19, 2023
Updated On:
Dec 19, 2023
