Regulatory Affairs Manager/ Менеджер по регуляторным вопросам

This position reports to Regulatory Affairs Lead.

Purpose: Manage and provide regulatory support for registration and maintenance of the products in the assigned Therapeutic areas (aTAs) on territory of EAEU and CIS.

Responsibilities:

Advance Product Support in aTAs: Submissions & Approvals:

• Coordinate handling of company core date sheet (CCDS) updates;
• Review promotional, non-promotional materials per agreed guidelines & within required timeframe;
• Provide support in defining and implementing regulatory aTAs strategy;
• Keep abreast of emerging legislation, local or international, related to registration and highlight the potential impact on the business;
• Gather a thorough knowledge of the registration files and all related company product documentation. Keep up to date on products in aTAs;
• Participation in Local brand-teams for aTAs and providing regulatory support for Commercial and Sales force;
• Create, review and sign registration submission dossiers prior the submission ensuring compliance of the dossier with local and corporate requirements;
• Ensure that all Regulatory submissions (new marketing authorisation applications, EAEU harmonizations, EAEU recognition, renewals, variations, notifications) are prepared and filed in a timely manner for all registered and new aTAs products in EAEU/CIS countries;
• Gain Regulatory Authority approval for Marketing Authorisations for new products;
• Maintain existing aTAs’ product Marketing Authorisations and gain Regulatory Authority approval of variations (amendments) to these authorizations as required;
• Manage any further information requests from local Regulatory Authority in a timely manner, ensuring local authority’s expectations are accurately translated for AbbVie Area Regulatory. Submission of any subsequent responses/product documentation updates to local Regulatory Authority;
• Maintain actual status for all submissions and approvals in aTAs in AbbVie RA electronical systems (e.g., AMP, AMS, Cosmos etc.);
• Review product labeling in accordance with legal and regulatory requirements; ensure that all labeling information is accurate, updated and approved by both Company and relevant Regulatory Authority in accordance with the Company policies and local regulations;
• Create Product Normative Documents in accordance with Company’s analytical guidelines and local regulatory requirements; ensure that all information is accurate, updated and approved by both Company and relevant Regulatory Authority;
• Provide and/ or manage translations of the documents, as required;
• Provide appropriate amounts and list of samples, reference standards, reagents and equipment required for pre-submission and registration testing of drug products;
• Provide necessary support in local pre-submission laboratory testing, if needed;
• Participate in packaging projects implementation within agreed timeframe, including development with third parties of updated artwork for cartons, labels and leaflets in accordance with Company requirements and local regulations;
• Assist in development and updating of local standard operational procedures;
• Improve professional skills and knowledge; attend Company’s and external educational events to increase qualification.

Regulatory Excellence: