Руководитель группы регистрации/ Regulatory Affairs Lead

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

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:

1. train and develop the personnel; demonstrate the practical use of best regulatory practices;
2. make timely plans for talent pool formation together with the Head of RA;
3. approve goals and objectives;
4. assess the effectiveness of activities (providing feedback and compiling a plan of employee development at least twice a year);
5. monitor the implementation of assigned tasks;
6. 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.

• 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.

AbbVie обязуется действовать честно, способствовать инновациям, преобразовывать жизнь людей, служить нашему обществу и поддерживать разнообразие и инклюзивность. Политика AbbVie заключается в приеме на работу квалифицированных специалистов с наибольшими способностями без дискриминации в отношении любого сотрудника или соискателя на работу по признаку расы, цвета кожи, религии, национального происхождения, возраста, пола (включая беременность), физической или умственной неполноценности, состояния здоровья, генетической информации, гендерной идентичности или самовыражения, сексуальной ориентации, семейного положения, статуса защищенного ветерана или любого другого юридически защищенного группового статуса.