Brief Description

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients’

lives by identifying, developing and commercialising meaningful products that address unmet medical needs. Our focus is on CNS/sleep, haematology/oncology and other areas in which our unique approach may be able to address significant treatment gaps.

The  Manager,  will  be  responsible  for preparing and/or overseeing regulatory submissions including the Clinical Trial Application (CTA), Marketing Authorisation Application (MAA), Variations and other post-approval submissions pertaining to the development, registration and regulatory compliance of Jazz products in the US or EU or International region as dictated by Jazz business objectives. The individual will be responsible for liaising and collaborating with in-country partners and consultants to ensure the compliance of the MA’s. The position will be responsible for comprehensive tracking of submissions and approvals and ensuring that the Jazz document management systems are accurately maintained.

This position will work closely with Regulatory Affairs colleagues and interact cross-functionally with members of the Clinical, Medical, Legal, Safety, Commercial, Quality and Supply Chain organisations.

Job Responsibilities and Requirements

• Participate as an active member of a multi-disciplinary team to establish regional regulatory strategies. Identify and communicate potential risks associated with strategy scenarios•  
• Support the preparation, review, and submission of briefing document for Health Authority meetings, CTAs or MAAs or post-approval regulatory submissions (e.g.variations, annual reports, periodic safety reports etc).
• Coordinate preparation and review of responses to Health Authority questions.
• Manage communication to Health Authorities verbally and written
• Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for regulatory submissions
• Manage review tracking systems for regulatory documents and promotional materials
• Enter data into Regulatory Databases
• Provide in-depth reviews of protocols, reports, presentations and documents
• Prepare and manage timelines to ensure approvals are timely and development objectives are met.
• Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support development of regulatory strategies
• Provide risk assessments and recommendations for various regulatory scenarios
• Participate in the electronic review and quality verification of regulatory submissions

Required Knowledge, Skills, and Abilities

• Bachelors or Master or advanced degree in a scientific discipline, with increasingly responsible regulatory experience in the pharmaceutical and/or biologics industries
• Demonstrated understanding and strategic application of regulations and guidelines for drug development
• Excellent English verbal and written communication skills
• Leadership ability within a team environment
• Ability to work with limited supervision, attention to detail, set priorities to meet timelines and to motivate and influence others
• Exceptional interpersonal skills with the ability to work individually, within a multi-disciplinary team, as well as with external partners and regulators