Regulatory Affairs Specialist

Janssen, pharmaceutical division of Johnson & Johnson, is looking for a candidate for Regulatory Affairs Specialist role based in Kiev, Ukraine.

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
• create requests for new packaging components, coordinate the process of implementation of new artworks, cooperate with all involved departments to ensure timely implementation of the artworks and compliant release of the products
• collaborate with wholesalers and State Service of Ukraine, prepare and provide all the necessary documents to obtain sales permits
• 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

Knowledge / Experience / Skills required:

• high education (preferably pharmacy, biology, chemistry (life sciences));
• 1 year + of related work experience preferred;
• upper-intermediate level of English is a must;
• good communication skills, careful to details, initiative, proactive