Regulatory Affairs Leader

Job Advertised by Pharmadiversity Job Board - The Regulatory Affairs Leader provides subject matter expertise in cell therapy with understanding of regulatory requirements for clinical and translational research. Works with a team of regulatory affairs professionals to ensure that GE Healthcare Life Sciences establishes best practice within the assigned area of responsibility, such as regional regulatory submissions & reporting, technical standards, collection and dissemination of intelligence, global regulation. Work closely with regulatory, engineering, marketing, legal and other professionals across the company to develop & implement company-wide programs and processes for regulatory affairs compliance within areas of responsibility. Identify regulatory trends and their implications for GE Healthcare; Develop & implement effective regulatory strategies to meet business objectives Analyze & communicate proposed, new or changing requirements & devise strategies for their implementation, ensuring business goals are met. Scan the external environment and work with external associations to proactively adapt regulatory strategies and influence change within areas of responsibility. Educate, train & advice company professionals to ensure compliance with RA requirements. Audit business units for compliance and consistency and track/address trends observed that could lead to non-compliance or risk to patient/user safety. Collect, summarize & evaluate performance metrics to identify program weaknesses & drive improvements in procedures or oversight. Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility. Bachelors Degree in Life Sciences or related discipline Regulatory Affairs experience from Biologics, Pharmaceutical or Medical Device industry or government / government relations Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner Ability to work well independently & in a team setting across cultures/countries/sites Has engaged with regulatory bodies to support development of regulatory requirements, such as the FDA Has worked with R&D, manufacturing and/or sales to establish regulatory compliant operational systems and processes. br/ br/ * For application attention if web source is requested please use PharmaDiversity or PharmaDiversity Job Board. br/ br/ APPLY FOR THIS JOB by going to ...http://www.pharmadiversityjobboard.com/view_job.php?post_id=581614&tag=aje