Organization: Sicor Biotech UAB, Regulatory Affais group (address: Molėtų pl. 5, Vilnius) POSITION CHARACTERISTICS: - Prepare/review and co-ordinate Chemistry, Manufacturing and Controls (CMC) regulatory filings to various health authorities.
- Develop, coordinate and implement global regulatory strategies for submissions of Teva's Branded products, from development through post marketing stage.
- Coordination, preparation and reviewing of CMC sections of registration dossiers, variations and other regulatory documents to ensure compliance with regulatory standards.
- Review and assess the change controls to establish the regulatory impact and prepare the global strategy for the implementation of the changes.
- Review of internal CMC controlled documentation having submission impact (stability protocols/reports, justification for changes, risk/benefit assessments, others).
POSITION REQUIREMENTS: - University degree in natural sciences (biology, biochemistry, biotechnology, chemistry) or equivalent;
- Previous work experience in new drug development, manufacturing or analytics;
- Working knowledge of EU and/ or US regulations / guidance applicable to registration;
- Ideally, working knowledge of relevant drug and biologics regulations and guidance including ICH guidelines, GCPs, GMPs, GLPs;
- Fluent Lithuanian and English language skills (verbal and writing);
- Advanced computer skills;
- Ability to work individually or as part of the group on special projects;
- Ability to work on multiple projects and tasks;
- Able (and willing) to shift focus among projects at short notice and under tight time requirements;
- Proactive and diligent.
If you are interested, please send your application and CV to cv@sicor.lt until January 31, 2016. |