Functions:

• Scientific advisor on regulatory dossier content:

- preparing protocols and evaluating reports for R&D studies (biowaivers, comparative quality studies/impurity profiling for generics)

- manufacturing process validation, analytical methods validation, stability studies

- bioequivalence and clinical study protocols by CROs

• Regulatory Affairs:

- assembling paper-based CTDs and eCTDs submissions

- regulatory communication with Ukrainian Authorities (registrations/renewals/variations)

• GMP certification:

- site inspections applications and off-site recognition of GMP certificates

- post-inspection CAPA follow-up u Quality Assurance

- managing local investigation of quality problems and reclamations

- reviewing quality documents for product consignments

• Management and documentation:

- team work with Regulatory Assistant

- writing SOPs and guidelines for internal regulatory practice

• Scientific Quality Reviewer (assessed for over 600 dossiers for registration of innovator and generic products, over 30 investigational medical products dossiers, over 100 renewal and variation submissions)
• Consulting Applicant's representatives on regulatory requirements and solutions for compliance
• Communications with foreign Regulatory Agencies
• Internal training speaker on topics of Quality, GMP, Regulatory practices