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 Head of Regulatory CMC will be responsible for leading a team to manage and lead registration and CMC regulatory support for commercial and development projects worldwide.
Responsible to ensure the team develop and deliver innovative, breakthrough global CMC regulatory strategies for global products across the Jazz portfolio.
- Team management and mentorship to Global team members both within the Global Regulatory Affairs CMC (GRACMC) team and broader Regulatory team. Provides direction to managers/directors across the team.
- Consults on or develops corporate and/or organizational policies and authorizes their implementation.
- Sought out for expertise and guidance by employees beyond own line of authority.
- Influences strategy to address internal or external business and regulatory issues. Proactively identifies potential strategic issues/opportunities.
- Uses knowledge of company, industry and area of expertise to propose solutions often beyond GRA.
- Performance management and Individual Development planning for all team members within GRA CMC.
- Ensure all activities are managed in a timely fashion including planning, writing and reviewing Module 2 and 3 CTD sections of all regulatory submissions ;internal review and submission; EU, US and Global commercial license maintenance.
- Oversee team members to establish development of Regulatory CMC strategies for commercial products and late and early stage development programs. Identify and communicate potential risks associated with strategy scenarios.
- Provide oversight on reviews of protocols, reports, presentations, and documents.
- Oversee and/or lead CMC related regulatory agency interactions.
- Manage timelines to ensure approvals are timely and corporate objectives are met.
- Monitor US, EU and Global CMC regulations, and assess any changes to ensure all development activities are in compliance with applicable current regulations and guidelines.
- Develop strategies for complex issues with potential for significant regulatory compliance impact. Ensure continued regulatory compliance of products though change control procedure.
- Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests.
- Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance.
- Ensure appropriate representation of GRACMC on key internal program/project teams.
- Ensure strategic regulatory input is provided to key development activities and documents.
- Facilitate exceptional regulatory CMC team performance by leading regulatory CMC team meetings and engaging GRA leadership for a strong and broad regulatory strategy and execution of regulatory deliverables.
- Ensure a well-functioning team and nurture an environment where all GRACMC team members have a voice.
- Pro-actively support the Global Regulatory 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.
- Communicate project updates and risks to Regulatory Leadership and other stakeholders across the organization. Track regulatory commitments and ensure timely execution of regulatory CMC 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
Required Knowledge, Skills, and Abilities
- Minimum 15 years of experience in Global Regulatory Affairs CMC.
- Experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory CMC 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 technical 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.
- Demonstrated ability to coordinate global activities.
- Experience in leading and managing 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.
Jazz Pharmaceuticals is an Equal Opportunity Employer.