Обязанности:
Regulatory Affairs Lead (Руководитель группы регистрации) This position reports to Head of Regulatory Affairs Russia & CIS Summary: Development and leading of implementation the regulatory strategy for registration and maintenance of the products in the assigned Therapeutic areas (aTAs) on territory of EAEU and CIS, including both L-AbbVie and L-Allergan products. Leading of the Regulatory Group responsible for assigned Therapeutic Area’s (Group). Responsibilities: Regulatory Excellence: Development of a registration strategy and maintain registration of aTAs in EAEU and CIS territory; Adhere to business plans and ensure implementation of the business strategy regarding regulatory topics; Represent the Group at external and internal events; Contribute to the preparation of Regulatory Affairs budgets and forecasts; Identify and track changes/trends in the authorisation practice and attitudes in Russia/EAEU and communicate them within the Company; Keep abreast of emerging legislation, local or international, related to registration and highlight the potential impact on the business. Team Management: Lead the aTAs RA Group; In cooperation with the Head of RA, take part in selecting, hiring, and dismissing group members and develop motivation systems for the Group; Build a reliable and effective Team: train and develop the personnel; demonstrate the practical use of best regulatory practices; make timely plans for talent pool formation together with the Head of RA; approve goals and objectives; assess the effectiveness of activities (providing feedback and compiling a plan of employee development at least twice a year); monitor the implementation of assigned tasks; motivate. Supervise the Group’s work: check the effectiveness of the Group’s work and their reports on a weekly and monthly (if necessary, daily) basis; Provide the Group members with all the necessary regulatory information (priorities, changes, business strategies, etc.) and organize regular Group meetings for shaping regulatory strategies and sharing best practices; Upon request, provide the Immediate Supervisor with further information/data on the progress of the work of the Group and each member of the Group. Advance Product Support: Submissions, Renewals & Approvals: Ensure that all Regulatory submissions (new registrations, renewals, variations, notifications) are prepared and filed in a timely manner for aTAs products marketed and/or registered in RU&CIS or new products intended to be marketed in RU&CIS; Participate in ARPTs (area regulatory product teams) for products under development as a representative of the RU&CIS RA in order to determine a strategy for registering products in the EAEU/CIS, including conducting clinical studies and putting together marketing authorization files in accordance with the applicable requirements; Gain Regulatory Authority approval for marketing authorisations for products in aTAs. Follow up with CMC and Labeling support of these submissions; 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; Coordinate handling of company core date sheet (CCDS) updates for aTA; Maintain TAs existing product marketing authorisations and gain Regulatory Authority approval of variations (amendments) to these authorizations as required; Gather a thorough knowledge of the registration files and all related company product documentation. Keep up to date on Company products; Support in defining and implementing aTAs regulatory aTAs strategy according to the National legislation and EAEU legislation; Review and sign-off registration submission dossiers prior to submission for aTAs ensuring compliance of the dossier with local and corporate requirements; Review Product Information in accordance with legal and regulatory requirements; ensure that all prescribing information is accurate, updated and approved by both Company and relevant Regulatory Authority in accordance with Company policies and local regulations; 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; Provide and/ or manage language translations, as required; Maintain actual status for all submissions and approvals in aTAs in AbbVie RA electronical systems (e.g., AMP, AMS, Cosmos etc.); Improve professional skills and knowledge; attends Company’s seminars for employees to increase their qualification; Participate in Local brand-teams for aTAs and providing regulatory support for Commercial and Sales force; Review promotional, non-promotional materials per agreed guidelines & within required timeframe; Provide support and, if required, back-up to other employees of the Regulatory Affairs Department; Assist in development and updating local standard operational procedures. Compliance/Training: Ensure compliance with AbbVie’s corporate policies, procedures and guidelines, local regulations to meet statutory, quality and business requirements within the overall strategy and objectives; Be the support function within the Affiliate for Regulatory-related activities. Qualifications: University degree in Pharmacy or Life Sciences. Post-graduate study, medical residency, or an advanced training course is considered a plus; Higher professional qualification in a scientific or business discipline desirable; Minimum of 5 years’ Regulatory Affairs experience in an associated company within the Healthcare Industry; Strong leadership and people management skills; Sound judgment, strong communication and negotiating skills; Excellent teamwork skills; Ability to be an effective leader without suppressing team members' initiative. Skills in negotiating with internal and external clients (including regulatory authorities); Highly developed project management skills; Able to work with big volumes of documents and texts; Attentive to details, responsible and well-organized; Comprehensive knowledge of LOCAL Regulatory Affairs and Pharmacovigilance requirements; Fluency in English both verbal and written; Efficient Computer Skills; Good presentation skills. Commitment to results. Conditions: Comfortable office in the center of Moscow (hybrid work format); Car allowance, medical insurance, meal and mobile allowance, annual bonus; The possibility of professional and career development.Похожие вакансии
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