Reference #: R009462 Brief Description: The Associate Director, Regulatory Affairs will be a key stakeholder in the company's regulatory activities and initiatives to ensure the quality of the company's records, products, and processes. He/she/they will support Jazz Pharmaceuticals' efforts to obtain worldwide approvals to market our products. An Associate Director, Regulatory Affairs within the Regulatory Strategy group will manage worldwide interactions and negotiations with regulatory agencies and marketing partners in support of investigational studies, product registrations, and commercial products. An Associate Director, Regulatory Affairs will be a key member of project teams and teams responsible for evaluation of product concepts. Essential Functions/Responsibilities

Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development

Serve as the Regulatory Affairs representative on project teams; assure the progress of projects by providing direction, solutions, and feedback to the teams

Lead regulatory interactions with health authorities, marketing partners, and vendors for their products/projects

Support the company's commercial products

Review and approve labeling for the company's products

Ensure the timely submission of INDs, NDAs, amendments, and supplements for their products/projects

Maintain awareness of and communicate changing regulatory agency requirements; provide training and regulatory intelligence to the organization Required Knowledge, Skills, and Abilities

A minimum of 8 years in roles of increasingly responsible in regulatory affairs or related areas in pharmaceutical drug development

Deep and broad knowledge of regulatory affairs; direct experience with pharmaceutical regulatory submissions and product approvals

Proven track record of effective collaboration with regulatory agencies, including FDA, EMA, and PMDA; experience with PMDA is a minimal requirement

Demonstrated leadership success in management of regulatory activities

Excellent verbal and written communication skills

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 Required/Preferred Education and Licenses

Masters or advanced degree in a scientific discipline preferred

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.