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