Jazz Pharma Oxford, UK
Oct 13, 2018Full time
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 This opportunity is available in Oxford, UK. 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 regulatory input into product development and life cycle management. He/she will support Jazz Pharmaceuticals' efforts to obtain worldwide approvals to market our products. The Associate Director, Regulatory Affairs 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 teams responsible for evaluation of product concepts. Essential Functions 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 or any relevant team; assure the progress of projects by providing direction, solutions and feedback to the teams Lead regulatory interactions with health authorities, manage document preparation, coordination rehearsals and minutes Manage meetings with marketing partners, and vendors for their products/projects Support the company's commercial products Review and approve labelling for the company's products Review of protocols, Investigator Brochures, IND/IMPDs, reports and all types of regulatory documentation (quality, safety, efficacy and labelling) including CTAs Ensure the timely submission of INDs/CTAs/IMPDs, MAAs/NDAs and variations for their products/projects Maintain awareness of and communicate changing regulatory agency requirements; provide training and regulatory intelligence to the organization Represent the company in external forum May manage junior regulatory professional Required Knowledge, Skills, and Abilities 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 Demonstrated leadership success in management of regulatory activities Experience with regulatory agency interactions and preparation of documentation to support interactions Possibly leader in agency interactions Knowledge of and possibly experience of special consideration opportunities WW Knowledge of international (WW) regulatory affairs (demonstrated by above) Experience in preparation of Regulatory strategies Experience with maintenance of regulatory authorizations in at least one region Experience with supporting a project with development activities in at least two regions Experience with working on early development projects (FIM) 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 Excellent verbal and written English and communication skills Some travel required Required/Preferred Education and Licenses Bachelors or Masters or advanced degree in a scientific discipline, with a proven track record of increasingly responsible regulatory experience in the pharmaceutical industry Description of Physical Demands Responsibilities may require working outside of "normal" hours, in order to meet business demands. Jazz Pharmaceuticals is an Equal Opportunity Employer.