Senior Associate, Regulatory Strategy
Category: Research & Development | Country: United States | State: California | City: Palo Alto | Type: Regular, Full Time | Job ID: 4439

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.

Responsibilities:

This position is responsible for supporting the Global Regulatory Lead in the preparation, review and submissions by interfacing with internal stakeholders to manage the submissions supporting marketing authorization applications, clinical trial applications, amendments, variations, responses to Agency questions, meeting request, briefing packages, and other types of regulatory submission documents.

Essential Functions

  • Support regulatory affairs team in preparation, review, and assembly of complex submissions
  • Help ensure the quality, accuracy and format of regulatory submissions and other documentation comply with applicable laws, regulations, and company standards
  • Participates in the electronic review and quality verification of regulatory submissions.
  • Researches and consolidates global regulatory requirements to enable future development of global regulatory strategies.
  • Participates in global regulatory team (GRT) meetings and advises the regulatory team on applicable regulatory requirements and project specific regulatory issues as assigned.
  • Models and adheres to the Jazz Behaviors, Values and Mission.

Required Knowledge, Skills, and Abilities

  • Minimum 3 years’ experience in Regulatory Affairs
  • Proven experience working in a Regulatory Affairs department, prior experience in relevant therapeutic area is preferred
  • Experience with eCTD format
  • Experience with preparation and maintenance of regulatory documents
  • Ability to manage timelines in a project team with guidance
  • Demonstrated problem solving
  • Excellent attention to detail
  • Strong communication skills (verbal and written)
  • Ability to manage multiple projects in a fast paced environment
  • Ability to define problems, collect data, establish facts, and draw valid conclusions
  • Basic understanding of regulations and guidelines for drug or biologics development
  • Ability to work independently
  • Less than 10% travel is required

Required/Preferred Education and Licenses

  • Bachelor’s Degree in Business or Life sciences is required, advance degree is scientific discipline is preferred

Description of Physical Demands

  • Occasional mobility within office environment.
  • Routinely sitting for extended periods of time.
  • Constantly operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.
  • Frequent computer use at workstation.
  • May move from one work location to another occasionally.
  • Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.
  • Occasional public contact requiring appropriate business apparel.

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.