Senior associate regulatory affairs - united kingdom, cambridge bay

*senior associate regulatory affairs* 12 month contract cambridge - uk gbp50 per hour 37.5 hours per week global biotech *role summary* we have an exciting opportunity for a senior regulatory associate (12-month contract) to join the global regulatory affairs oncology & anti-infective team (uk-based team) to support regional activities primarily focussed on the the ic & gps (intercontinental and global patient solutions) region which includes territories throughout asia, latin america, africa, eastern europe and the middle east. although this is the primary focus regional activities may cross into the ace (australia, canada, switzerland, gb and eu region if required). the uk-based team provides strategic and technical advice from development throughout the whole product lifecycle for all oncology/anti-infective projects/products. the team's core activities are to plan, prepare and progress new product registrations and subsequent post-approval safety and indication updates. we work cross-functionally with a diverse number of stakeholders both internally and externally. the team works on a broad portfolio of products and can offer the opportunity to work on a diverse range of regulatory activities. the team and regulatory department as a whole is built on a strong sense of team work. *essential duties and job functions for this role* * responsible for supporting regulatory strategies and preparing submissions for designated products. submission types include new product licenses to lifecycle activities and role will support all regulatory aspects of these applications * support post-marketing activities for the preparation of regulatory submissions in given markets outside of the ace region, which may include, but is not restricted to variations, psurs/rmps, responses to questions and renewals. * prepare and maintain labelling to support new product applications and other post-licensing activities primarily in the ic region. ensure that any updates to the product company core data sheet (ccds) are implemented in a timely manner in the impacted local market * assist in ensuring product packaging and associated information is updated and maintained in accordance with product licences in designated territories including the co-ordination of labelling translations as required. * support post-marketing activities for the preparation of regulatory submissions via the eu centralised procedure, which may include, but is not restricted to variations, psurs/rmps, responses to questions and renewals if required. * participate in ra team meetings, product team meetings and departmental meetings. * use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies. *key role-related competencies* * able to facilitate/impact effective interactions and discussions * able to effectively interact to information gather and effectively drive projects through to completion to tight timelines. * a good scientific background and understanding *education and/or experience required* * life sciences degree * relevant experience in regulatory affairs * an understanding of regulatory requirements ic/gps region. * experience in supporting post-licensing management of variations, renewals, responses to questions, follow-up measures, psurs etc for ic/gps region. * experience with working with document management systems (eg. rdms and gplm). *core competencies* * excellent oral and written english communication skills * excellent planning and organizational skills with the ability to work simultaneously on a number of projects with tight timelines * demonstrated effectiveness in cooperation and teamwork with analytical and assessment skills. * planning and information seeking skills and ability to work on specific tasks with minimal supervision. * problem solving, strategic thinking skills with ability to impact and influence * attention to detail with accuracy and quality * ability to understand and effectively relate to external and internal customers * business awareness and professionalism

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