Regulatory Affairs, Senior Specialist/Manager
Yesterday
Description
•Assume leadership and functional representation for projects and/or deliverables of medium/high complexity ensuring effective and rapid coordination and management and execution of SSU/regulatory tasks •Develop strategy and manage set up activities (SSU RA Management Plan, procedures and core documents) ensuring compliance and consistency with department standards •Support team members in preparing project strategy, identifying issues and providing resolution •Author/contribute towards the preparation and/or review of complex technical/scientific/legal documentation •Ensure preparation, collection, review of regulatory information and documents to support submissions to FDA, EMA and national authorities (CTA/INDs, MAAs/NDAs/BLAs, ODDs, PIPs) as well as Ethic Committees/IRBs for initial authorization and maintenance, in compliance with the applicable regulations •Provide expert advice to Clients addressing complex regulatory queries ensuring consistent and high-quality advice across all regions •Ensure that all communications with Regulatory Authorities and Ethics Committees/IRBs are carefully tailored to the specific requirements and take place only when essential guidance cannot be obtained through other available resources •Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS •Assist in securing new business or repeated business by participating in BDMs, developing and reviewing regulatory sections of proposals, regulatory costing and budgets •Provide training, coaching and mentoring to junior members of staff.
Requirements
•Bachelor's Degree in Chemistry, Life Sciences or Medicine •Minimum 3 years within CRO industry •Proven ability to successfully manage global projects •Expert knowledge of ICH GCP and/or GVP and comprehensive understanding of relevant legislation/ regulatory requirements globally •Very good written and verbal communication skills to clearly and concisely present information
Benefits
•Training and career development opportunities internally •Strong emphasis on personal and professional growth •Friendly, supportive working environment •Opportunity to work with colleagues based all over the world, with English as the company language
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