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Associate Director, Regulatory Affairs

Overview

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.

Position Profile

The Associate Director, Global Regulatory Affairs, at Jazz Pharmaceuticals will be a key stakeholder in the company's global 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. The 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. The Associate Director, Regulatory Affairs, will be a key member of project teams and will be responsible for evaluation of product concepts, especially for the EU and ROW.

This opportunity is available in Oxford, UK.

Essential Job Functions:

Job Responsibilities and Requirements:

• Develop and implement EU/ROW regulatory strategies to facilitate the progress of programs in all phases of development.

• Serve as the EU/ROW 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 developmental and commercial products.

• Review and approve labeling for the company's products.

• Ensure the timely submission of briefing books for Regulatory meetings, CTAs, MAAs, Variations etc. 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 EU/ROW Regulatory Affairs or related areas in pharmaceutical drug development.

• Deep and broad knowledge of EU/ROW Regulatory Affairs; direct experience with pharmaceutical regulatory submissions and product approvals.

• Proven track record of effective collaboration with international regulatory agencies including the EMA, CHMP, National Authorities and other international regulatory agencies.

• 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.

Jazz Pharmaceuticals is an Equal Opportunity Employer.

Associate Director, Regulatory Affairs

Oxford, UK
Full Time

Published on 04/25/2020