Johnson & Johnson Careers

Regulatory Affairs Specialist

Kiev, Ukraine
Regulatory Affairs


Job Description

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).
 
Main Responsibilities:
  • 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
 

Qualifications
  • 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
 

Primary Location
Ukraine-Kyyivs'ka-Kiev
Organization
J&J Ukraine (8434)
Job Function
Regulatory Affairs
Requisition ID
00001CNW