Regulatory Affairs Senior SpecialistManager
Regulatory Affairs Senior SpecialistManager
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Job Description
Ergomed is looking for a Regulatory Affairs professionals with indepth experience in managing global complex clinical studies.
Opportunities are open to any geographical location; however candidates will be required to possess excellent written and communication skills in English as well as good understanding of clinical trials environment/ICH GCP.
Main responsibilities for the role are:
- 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 driving the team to meet the agreed targets and to comply with the agreed procedures trackers and templates.
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 issue 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 authorisation and maintenance in compliance with the applicable regulations.
Provide expert advice to Clients addressing complex regulatory queries ensuring consistent and highquality advice across all regions.
Ensure that all communications with Regulatory Authorities and Ethics Committees/IRBs are carefully tailored to the specific requirements and tale 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 to BDMs developing and reviewing regulatory sections of proposals regulatory costing and budgets.
Provide training coaching and mentoring to junior members of staff.
Qualifications :
- Bachelors 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
Remote Work :
Yes
Employment Type :
Fulltime
Employment Type
Remote
