Associate Director, Regulatory Affairs Jobs in Palo Alto, CA at JAZZ PHARMACEUTICALS PLC

Title: Associate Director, Regulatory Affairs


Location: Palo Alto, CA

Salary: $100K — $150K *

Category: Pharmaceuticals & Biotech

Job Description


An Associate Director, Regulatory Affairs at Jazz Pharmaceuticals 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 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.

This opportunity is available in both Palo Alto, CA andPhiladelphia, PA

Essential Job Functions:

Job Responsibilities and Requirements:

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

Minimum Requirements:

Bachelors or Masters or advanced degree in a scientific discipline, with a minimum of 8 years in roles of increasingly responsibility 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 the FDA

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

Some travel required

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Valid through: 8/14/2020