Director Regulatory Strategy - Licensed Products
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.
Director, Regulatory Affairs at Jazz Pharmaceuticals will be a key stakeholder in the company's regulatory activities and initiatives to oversee regulatory activities of product development and life cycle management for licensed products. He/she will support Jazz Pharmaceuticals' efforts to obtain and maintain agreements with Health Authorities globally to market our products. The Director, Regulatory Affairs will manage worldwide interactions and negotiations with regulatory agencies, internal stakeholders, and partners in support of product registrations and continuity of supply. He/she will be a key member and may lead project teams while also overseeing junior regulatory team members.
- Manage partnerships from regulatory standpoint for products/projects
- Support the company's commercial products
- Review and approve labelling for the company's products
- Review documentation in support of commercial product (I.e. clinical protocols/CSRs and investigator brochures, quality, nonclinical, safety)
- Ensure the timely preparation, review, and submission of investigational and product submissions such as INDs/CTAs/IMPDs, MAAs/BLAs/NDAs and variations for products/projects
- Oversee direct reports in preparation and management of above responsibilities and assist as needed
- Required Knowledge, Skills, and Abilities
- Deep and broad knowledge of regulatory affairs and requirements; direct experience with biological and/or pharmaceutical regulatory submissions and product approvals
- Proven track record of effective collaboration with regulatory agencies
- Demonstrated success in management of regulatory activities
- Experience with regulatory agencies and preparation of documentation to support interactions
- Ability to lead agency interactions
- Knowledge and experience in preparation of investigational and new product submissions with EU, US, and ex-US countries including eCTD format
- Experience in preparation of global regulatory strategies
- Experience with maintenance of regulatory authorizations and variations in at least two regions
- Experience with supporting a project with development activities in at least two regions
- Experience working on cross-functional teams
- Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions
- Ability to work with limited supervision, to set priorities to meet timelines, and to motivate and influence others
- Experience managing and mentoring junior regulatory professionals
- Proficient in verbal and written English, with excellent communication skills
- Some travel required
Required/Preferred Education and Licenses
- Bachelors or Masters or advanced degree in a scientific discipline, with a proven track record of increasingly responsible regulatory experience in the pharmaceutical and/or biotech industry
Description of Physical Demands
- Responsibilities may require working outside of "normal" hours, in order to meet business demands
Jazz Pharmaceuticals is an Equal Opportunity Employer.