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 Global Regulatory Lead (GRL) will be responsible for developing and delivering innovative, breakthrough global regulatory strategies for a product in assigned therapeutic area. 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 Global Regulatory Affairs.
- Act as member of Global Molecule Team:
- Represents Global Regulatory Affairs (GRA) as a member of the cross functional Global Molecule Team (GMT). Responsible for ensuring collaboration with key internal stakeholders of the GMT and the Development Core Team (DCT) to ensure successful planning and execution of the global regulatory strategy for assigned program(s).
- Accountable for the development and maintenance of a global regulatory strategy plan. In conjunction with GRT 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.
- Develop strategies for complex issues with potential for significant regulatory compliance impact
- Ensure appropriate representation of regulatory 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.
- Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance
- Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests
- Consult with and advise legal counsel on regulatory and legal issues
- Lead Global Regulatory team for assigned molecule(s):
- Facilitate exceptional regulatory team performance by leading regulatory team meetings (GRT) and collaborating with regional regulatory strategists, regulatory sub-function representatives, and engaging GRA leadership for a strong and broad regulatory strategy and execution of regulatory deliverables
- Ensure a well-functioning GRT and nurture an environment where all GRA team members and functions have a voice
- Pro-actively support the regional strategy leads on the establishment and maintenance of high quality working relationships with regulatory agencies as appropriate for assigned therapeutic areas and products. Includes effective planning and presentation of key meetings with Health Authorities to ensure full discussion of issues and opportunities.
- Work with the GRT for preparation of clear and effective Regulatory submissions e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplements and other relevant regulatory filings.
- Depending on the program assignment, the GRL may also serve as the Regional Strategy Lead
- Responsible for ensuring requirements to maintain marketing applications and regulatory approvals are achieved within specified timelines. Oversee and work with regional leads (EU/RoW and US) to ensure consistent approach within molecule and maximize regional efficiencies.
- Accountable to GRA and the organization:
- Communicate project updates and risks to Regulatory Leadership and other stakeholders across the organization. Track regulatory commitments and ensure timely execution of regulatory deliverables
- Monitor and analyze appropriate regulatory agency activities and industry precedence in areas of interest to the company, and assess impact on programs
- Support Global Regulatory Leadership team in developing and adhering to functional area operational budgets for all programs
- Mentor Regulatory team members and guide direct reports in carrying out responsibilities. Responsible for coordinating activities and career development of direct reports
- Assist department leadership in Identifying the need for new regulatory policies, procedures and SOPs, and writing/approving them
- Other duties as assigned
Required Knowledge, Skills, and Abilities
- Minimum 15 years of experience in Global Regulatory Affairs, including a minimum of 10 years’ experience in drug development and registration activities; prior experience in relevant therapeutic area strongly preferred
- Experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies
- Thorough knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US, EU, Japan)
- Track records of issue resolutions with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
- Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
- Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
- Ability to broadly represent department functions on project team in a matrix organization. Demonstrated ability to coordinate global activities
- Experience in leading and managing matrix teams (minimum 3-5 years), setting clear direction, holding people accountable and fostering a collaborative team environment
- Prior line management experience in a global organization
- Excellent verbal and written communication skills and collaborative interpersonal skills
- Ability to broadly represent department functions on project team in a matrix organization and demonstrated ability to coordinate global activities
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.