Компания "AbbVie"
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.