ClinChoice
Full-Service CRO • Clinical Development • Post-Marketing & Real-World Evidence • Quality and Compliance • Technology
1001 - 5000
Regulatory Affairs Specialist - Consultant
5 days ago
ClinChoice
Full-Service CRO • Clinical Development • Post-Marketing & Real-World Evidence • Quality and Compliance • Technology
1001 - 5000
Description
• Responsible for the implementation of regulatory strategies, obtain and maintain marketing authorizations for products and provides communication of general regulatory requirements in support of licensing of Clients products. • Contact point for local regulatory authorities regarding products in Slovakia • Monitor applicable regulatory requirements; assure compliance with client and external standards • Establish appropriate communication within RA and with other functions • Perform regulatory gap analysis and propose solutions • Develop and document sound regulatory decisions and justifications • Ensure regulatory strategies are aligned with project teams and country business objectives • Review promotional material and SOPs for compliance with local and global regulations • Partners with country business in country goals achievement • Represent RA function on assigned cross-functional project teams
Requirements
• Bachelor's degree or country equivalent in pharmacy or related scientific discipline with a minimum of 2 years • years regulatory experience within med tech/ pharmaceutical company, CRO or similar organization. • Higher degree/PhD will be an advantage. • Number of years of experience: 2 • Field of expertise: RA in medtech/ pharmaceutical company, CRO or similar organization. • Spoken Written Read English • Basic knowledge required • Microsoft Office tools, interest in IT applications, experience with RIM is an advantage
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