Regulatory Affairs Manager/ Менеджер по регуляторным вопросам

Описание

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: Cooperate and liaise with manufacturing sites, corporate head-office, Area and other Company departments; Establish and maintain good relationships with all involved regulatory institutions in EAEU/CIS countries; Identify and track changes/trends in regulatory approaches and practices in EAEU/CIS and communicate them within the Company. Regulatory support for other Company functions: Sales and Marketing, Quality Assurance Department, GMP inspections, Medical Affairs department, Regional/global functions. People/Talent: Provide training of newcomers on relevant Regulatory processes and systems when necessary. Requirements: University degree in Pharmacy, Chemistry or Life Sciences; Minimum of 3 years’ Regulatory Affairs experience in an associated company within the Healthcare Industry; Adequate judgment, strong communication and negotiating skills; Teamwork skills; Comprehensive knowledge of local Regulatory Affairs requirements; Able to work with big volumes of documents and texts; Attentive to details, responsible and well-organized; Fluency in English both verbal and written; Good presentation skills; Efficient Computer Skills. Conditions: Comfortable office (hybrid work format); Medical insurance, meal and mobile allowance, annual bonus; The possibility of professional and career development.