Senior Regulatory Affairs Specialist/Manager
2 days ago
Description
• Ergomed is looking for a Regulatory Affairs professional with in-depth experience in managing global complex clinical studies. • Assume leadership and functional representation for projects and/or deliverables of medium/high complexity. • Develop strategy and manage set up activities 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. • Provide expert advice to Clients addressing complex regulatory queries. • Ensure all communications with Regulatory Authorities and Ethics Committees/IRBs are tailored to specific requirements. • Monitor project budgets and promptly identify and escalate any OoS. • Assist in securing new business or repeated business by participating in BDMs.
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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