Alisa Falkova

The objective of this position is to ensure the successful, smooth and on-time implementation of the company project at EMEA local operation companies by:
• Serving as a regulatory affairs (RA) coordinating contact of the strategy implementation for the EMEA (SEE & MEWA) project team and local operating companies (LOCs);
• Coordinating and tracking countries requirements to support optimal project strategy for individual country or cluster in SEE & MEWA;
• Coordinating specific requirements with other stakeholders as Global Labelling center of excellence, reference LOCs, translator and others identified by the LOC or Coordinator;
• Proposing actions to accelerate the process, eliminate redundancies or, if needed, corrective actions to meet the deadlines and compliance objectives;
• Ensure achievement of project goals in SEE & MEWA by proactive support of regional needs in identification of reference countries, collecting reference country labelling submission package, fulfillment of company's SOPs and WI applicable to labelling process;
• Shape the drug labelling process from RA perspective by sharing regulatory SOP and best practice knowledge and experience, proposing actions to ensure regulatory compliance;
• Share experience and best practices in following global labelling processes; supervise the team in a new process of labelling updates, approval and implementation.

The objective of this position is to provide full regulatory support of products portfolio in Ukraine by leading a team of 2 specialists, development and implementation of regulatory strategy, regulatory submissions (e.g., MAAs, renewals, variations, line extensions) in accordance with local regulations, liaising between Regulatory Affairs and other functional areas, ensuring regulatory compliance, authoring and reviewing standard operating procedures (SOPs) and ensuring compliance with current regulatory requirements, maintaining current regulatory knowledge and tracking regulatory software systems, people management and coaching.

The objective of this position was to provide regulatory support for company’s Legal Entity Integration (LEI) project and Merge-related Activities in Ukraine.

Duties and responsibilities
• Plan regulatory activities together with EMEA-Regional Regulatory Integration Liaison Department
• Support EMEA team with all regulatory requirements of Ukraine to ensure accurate documentation sets were provided for filing
• Provide technical review of documents required for regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation (administrative documents, CMC part)
• Support IPP (integrated project plan) database for all LEI and Network Projects
• Support local GMP-compliance procedure for all involved manufacturing sites, including preparation of submission files according to local regulations, submission to HA and procedure follow-up.
• Maintain knowledge database of existing and emerging regulations, and guidance documents.

Achievements
By coaching colleagues on the new at that time procedure of local GMP-recognition in Ukraine and help in liaising with internal and external manufacturing sites, together with RA team achieved smooth and extremely quick obtaining of recognition certificates for more than 50 company’s manufacturing sites.

The main task of this position was to provide full support of regulatory activities of local operating company.

Duties and responsibilities
• Perform analysis of existing regulatory problems with company’s portfolio, develop corrective actions plan and local regulatory strategy for company’s products
• Prepare and coordinate MAAs, renewals and other regulatory submissions, compile registration dossiers for submission to MOH according to local legislative requirements
• Support local GMP-compliance procedure for company’s manufacturing sites, including preparation of submission files according to local regulations, submission to HA and procedure follow-up
• Prepare and revise patient’s information leaflets and mock-ups according to the reference country and regulatory guidelines
• Fulfill company standard operating procedures
• Support company regulatory databases

The major task in this job was to provide company’s clients with regulatory service at the territory of Ukraine and CIS countries. My responsibilities included preparation and presentation of registration documents to regulatory agencies, all the subsequent negotiations necessary to obtain and maintain marketing authorization for the products concerned, managing and training a staff in the preparation of all applications and dossiers for registration of pharmaceuticals, medical devices, BAS and cosmetics.

Duties and responsibilities
• Assess scientific content of new registration packages of pharmaceutical drugs (generics) and medical devices to ensure they comply with government regulations prior to submission to Health Authority.
• Check documents and product dossiers prior to submission to ensure correct and acceptable information was provided.
• Prepare and submit applications and dossiers to appropriate government agencies.
• Prepared CMC documents for query reply, including quality documentation, product specifications, stability protocols, and chemical studies.
• Prepare dossiers in СTD format from client’s internal dossier formats.
• Monitor the process of market authorization through relative state body of Ministry of Health, ensured timely management of license variations and renewals.
• Supervise the team of three employees (regulatory specialists).

Achievements
Obtained marketing authorization certificates for more than 50 pharmaceutical products for customers from Germany, India, UAE, France and Russia. Established strong mutual relations with new clients and renewed cooperation with former customers. Developed partners’ network in CIS countries, Europe, India, USA, and Australia.