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 Expansion Lead will be responsible to manage and lead registrations and provide regulatory support in defining the regulatory strategy for assigned products covering International markets and regional regulatory expertise in collaboration with partners.
The individual is responsible for executing the regional regulatory strategy pertaining to the development, registration and regulatory compliance of Jazz products in the International markets as dictated by Jazz business objectives. This will include interacting with the relevant groups as needed to ensure timely submission and approval for Jazz products in these markets.
- Overall cross functional planning and execution lead.
- Works closely with Commercial to assess and define a Global expansion plan per product.
- Responsible for coordination with GMT, GRT, Jazz stakeholders and external partners.
- Member of Global expansion steering committee.
- Provide international regulatory strategy support for assigned products (maintaining and extending Jazz product registrations in International markets).
- Collaborates closely with all other key GRA stakeholders (including but not limited to Global Regulatory Lead, labelling, CMC, regulatory operations, EU regulatory team to ensure that all aspects of the regional strategy is coordinated and considered.
- Provides regional regulatory expertise to GRL and within GRT by collaborating with our partners in International markets.
- Ensure international strategy is appropriately represented within the GRT and at other appropriate forums (Global Development Team etc.) through the GRL.
- Works in close collaboration with the GRL and partners in providing support to meetings with Health Authorities.
- Lead cross-functional submission teams to ensure creation and submission of qualitative regulatory documents (MA, Briefing documents, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives.
- Acts as International regulatory strategy contact for all applications related to the assigned product in the International region including coordinating with functional stakeholders to ensure the timely submission, approval and compliance of all applications.
- In collaboration with cross-functional team, ensure timely updates to product core dossiers for the assigned products.
- Communication and collaboration with relevant stakeholders including GRLs and Senior Management to ensure they are fully informed of all activities within the regions.
- Ensures that regulatory submission and approval notification is communicated to appropriate functions within the defined timeframe to allow implementation.
- Ensure appropriate archiving of all submissions performed in international markets by collaborating with Regulatory Operations.
- Collaboration and support for the review, approval and implementation of regional labelling.
- Remains knowledgeable about current regulations and guidance.
- Provides support to GXP inspection activities as required.
- Ensures all regulatory documentation is stored within Jazz systems in accordance with Jazz standards
Required Knowledge, Skills, and Abilities
- Knowledge of International regulatory requirements.
- Ability to challenge self to overcome barriers and deliver high quality solutions to the business.
- Understanding of the drug development process and laws and regulations affecting pharmaceutical development in International region.
- Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
- Excellent interpersonal, communication, analytical, and organizational skills.
- Working in a matrix structure and with cross functional teams, requiring negotiation and partnership skills.
- Good understanding of drug/biologics development within pharmaceutical and biotechnology industry or Government Health Agency.
- Experience interfacing with regulatory agencies and proven skill at developing and implementing successful global regulatory strategies.
- Track records of issue resolutions with regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
- Demonstrated ability to coordinate global activities.
Required/Preferred Education and Licenses
- Bachelor degree minimum, Masters, or other advanced degree in a scientific discipline preferred
Jazz Pharmaceuticals is an Equal Opportunity Employer.