Johnson & Johnson Careers
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Regulatory Affairs Specialist
Requisition ID: 00001CNW
Janssen, pharmaceutical division of Johnson & Johnson, is looking for a candidate for Regulatory Affairs Specialist role based in Kiev, Ukraine (maternity leave vacancy).
- handle regulatory submissions (MAAs, renewals, variations), compile dossiers in accordance with company and local legislation requirements, perform all the necessary activities related to product registrations for the assigned products – order necessary documents for submissions, analyze dossiers, prepare methods of quality control, instructions for medical use, etc;
- communicate with SEC, follow up registration procedures at all stages
- participate in the process of new artwork implementation, contribute to the compliant release of the products
- communicate with the manufacturing sites, prepare and submit documents for GMP confirmation in Ukraine
- track regulatory databases, maintain high level of compliance, ensure reporting accuracy is maintained
- fulfill Company’s standard operating procedures
- high education (preferably pharmacy, biology, chemistry);
- related work experience min 1 year preferred;
- intermediate level of English is a must;
- good communication skills (collaborative approach), careful to details, initiative, proactive
J&J Ukraine (8434)