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 EU/RoW Regulatory Strategy Lead is a key member of the GRA department and is responsible for working in a matrix environment to manage and lead registration, compliance and regulatory support of commercial and development projects in EU/RoW.
The position is expected to closely collaborate with US and Global colleagues to guide the strategic plans, to deliver and maintain high quality submissions and to ensure Regulatory compliance in order to achieve business success.
- Advise on issues and propose solutions to ensure all regulatory Eu/RoW 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.
- Keep abreast of changing regulations and guidelines on drug development and registration and disseminate intelligence on EU regulatory matters to management and regulatory colleagues, as required.
- Accountable to provide site leadership and mentor members of global regulatory affairs within the Oxford office
- Advise on resource, work prioritization and input to cost and budget control.
- Provide extensive, up-to-date regulatory expertise on current development and marketing authorisation requirements and procedures to develop innovative strategies that drive faster (to market) product development, regulatory approval and launch penetration in EU/RoW
- Provide oversight of regulatory activities in affiliate countries, as needed
- Support product development life cycle management strategies including new indications/geographic expansions for existing products to maximise portfolio value.
- Responsible and accountable for the Eu/RoW systems and procedures and provide Eu/RoW management input to support Global Regulatory Affairs GXP compliance.
- Advise on the development, maintenance and optimization of relationships with internal and external customers e.g. e.g. Relevant Regulators, Key Policy Thought leaders.
- Advise the business in order to meet its needs and to represent the EU/RoW Strategy function (and the Global Regulatory Affairs function, as required).
- Additional duties as assigned
Required Knowledge, Skills, and Abilities
- Proven track record of ever increasing responsibility in Global Regulatory Affairs, demonstrable depth of experience in drug development and registration activities; commercial awareness and prior experience in relevant therapeutic area(s) strongly preferred
- Proven track record of effective collaboration with the EMA and/or other regulatory agencies globally in gaining pharmaceutical product approvals and defending established products
- Track record of issue resolution with main regulatory authorities; demonstrated ability to break down complex, scientific content into logical components.
- Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies
- 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
- Ability to consistently balance the needs of commercial strategy, drug development, and regulatory compliance
- Excellent verbal and written communication skills and collaborative interpersonal skills
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.