Associate Director, Regulatory Affairs (Remote)

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.

Job 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
• 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.

FOR US BASED CANDIDATES ONLY
 

Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is:

$152,000.00 - $228,000.00

Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy.