Jazz Pharmaceuticals

Head of Global Regulatory Affairs

US-CA-Palo Alto
4 days ago
Job ID
2017-3307
# of Openings
1
Category
Research & Development

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

Purpose Statement

The Head of Global Regulatory Affairs will be responsible for managing and leading registration, compliance and regulatory support of commercial and development projects globally.

Key Responsibilities

  • Shaping and executing regulatory strategies against overall portfolio development and lifecycle management strategy in collaboration with the Commercial, Clinical, Technical Operations, Finance and Legal teams as well as with the R&D executive leadership of Jazz Pharmaceuticals
  • Serve as  leader and spokesperson  with worldwide Regulatory Authorities
  • Ensure all regulatory submissions including original marketing applications, clinical trial applications, amendments, supplements, variations, responses to Agency questions, meeting requests, briefing packages, annual reports, periodic safety reports, etc. are   prepared to the highest quality and submitted in a timely manner
  • Ensure compliance and adherence to regulations and applicable guidelines for all regulatory submissions
  • Manage resources to ensure that approvals are timely and development objectives are met
  • Provide risk assessments and recommendations for various regulatory scenarios
  • Provide leadership and mentoring for all staff in Global Regulatory Affairs

Essential Requirements

  • Education:  Bachelor, Master, PhD, or medical degree with a minimum of 15 years of regulatory experience
  • Highly self-motivated and comfortable operating in an entrepreneurial and decentralized environment
  • A demonstrated track record of driving performance and leadership ability within a team environment
  • Demonstrated ability to attract, build and motivate a regulatory team of high-functioning individuals
  • Highly resilient and achievement-oriented, with the ability to succeed in an environment that demands fast but well-founded decision-making on a vast number of multidisciplinary issues
  • Demonstrated ability to consistently balance the needs of commercial strategy, drug development, and regulatory compliance
  • Proven track record of effective collaboration with regulatory agencies globally in gaining pharmaceutical product approvals and defending established products
  • Exceptional written and verbal communication skills

Jazz Pharmaceuticals is an Equal Opportunity Employer.

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