Руководитель группы регистрации/ Regulatory Affairs Lead

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:

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.

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.