В фармацевтическую компанию AbbVie требуется 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 authorization 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 authorizations 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 authorizations 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
Requirements:
- 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