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Job Description
ROLE PURPOSE:
The role is critical to lead the regulatory function in Belarus and drive national and EAEU regulatory strategy to ensure product availability and business continuity in the Belarus market and across the EAEU region, by:
- Delivering on-time product registrations and lifecycle maintanance of already registered products through timely submissions and approvals while maintaining strong engagement with Health Authority.
- Ensuring import batch testing and certification of the products, directly impacting release timelines and uninterrupted supply in Belarus.
- Lead for RA LOC team in Belarus
- Align ovearall regulatory startegy with local & regional regulatory team .
This role helps ensure compliance with legislation and regulations, contributing to the organization's operational stability and success.
KEY JOB RESPONSIBILITIES:
- Effective Team lead for Belarus RA team in order to meet expected RA timelines and KPIs.
- Responsible to prepare and execute optimal regulatory strategies aimed to deliver product approvals and/or life cycle management in accordance with the regulatory objectives of the regional business to enable ultimate strategy and faster access to innovative medicines in the region.
- Develop effective relationships with local commercial organization, distributors cross functional team and service providers if needed in the region.
- Lead RA strategy & registrations: Develop and execute Belarus/EAEU regulatory strategy and all submission types for medicines, medical devices, and other relevant products in alignement with regulatory head for Russia & Belarus
- Implements the state registration procedure, as well as manages the state registration (renewal) and submission/approval variations to the registration dossier for medicines, including pharmaceutical substances and medical devices, in Belarus, in accordance with regulatory legislation.
- Responsible for liaising with the EAEU Registration Group in order to agree on the strategy, timing and information in the registration dossier planned for registration in Belarus or in cases where it is planned to change the registered information.
- Determines the registration strategy and types of registration procedures for medicines, medical devices in its area of responsibility.
- Responsible for the formation of the budget for drugs in his area of responsibility, taking projects in its area of responsibility. into account the planned registration activities.
- Responsible for and controls the timely fulfillment of the deadlines for the formation of registration dossier and the passage of registration procedures in the area of his responsibility.
- Responsible for maintaining up-to-date information on planned or completed regulatory activities in the company's RIM (regulatory information management) systems.
- Supervises the timeliness and correctness of the procedures for the development, coordination and approval of packaging materials, procedures for checking and approving medical and promotional information by direct subordinate employees.
- Provides the company's divisions with a monthly report on the current status of registration
- Ensure patient access & supply continuity: close follow with local HA to secure approval in alignment with the local legislation requirementsand lifecycle maintenance to secure uninterrupted access to therapy.
- Provide expert regulatory guidance to market access, medical affairs and patient access functions, including regulatory support for cross-functional projects.
- EAEU GMP certification support: coordinate GMP application submissions and GMP inspections to obtain/maintain EAEU GMP certificates for Takeda and partner manufacturing sites
- Compliance, governance & quality system: Oversee local SOPs and work instructions, regular self-inspections, and regulatory risk management in line with Belarusian law and Takeda standards:
- Responsible for maintaining the relevance of standard operating procedures in his area of responsibility and developing a schedule for their revision.
- Monitors regulatory legislation, adjusts the work plan if necessary.
- Observes and ensures compliance with the legislation of the Belarus/EAEU, the Company's compliance procedures and policies, the rules of business etiquette, and ethical business practices adopted by the Company and the industry in its area of responsibility.
- Team & performance leadership: Manage and develop the RA team, enhancing team capabilities:
- Creates an effective team of subordinate employees and ensures its effective work.
- Analyzes the performance of subordinate employees, gives timely feedback, adjusts tasks, moni-tors the implementation of goals and objectives.
- Provides conditions for the professional development of subordinate employees using various methods and approaches, in accordance with the established procedures and standards of the company, including individual development plans
- Ensures timely familiarization of subordinate employees with changes related to their work ac-tivities and relevant documentation.
- Participates in the selection of new employees in accordance with the approved staffing table and the plan for filling vacancies.
- Ensures delivery of regulatory KPIs.
- Performs individual tasks and instructions of the immediate supervisor as part of the work process.
REQUIRED QUALIFICATIONS:
- Higher education (medical, pharmaceutical, chemical, or biological degree required).
- At least 5 years of relevant experience in a similar role, with proven leadership skills.
- Strong knowledge of local pharmaceutical market legislation and the Belarus/EAEU regulatory framework.
- Experience in the registration of medicines, pharmaceutical substances, and medical devices, including preparation of regulatory dossiers/submissions and effective interaction with health authorities to ensure favorable outcomes.
- Experience representing the organization professionally in dealings with regulatory bodies.
- Ability to manage and file complex product notifications and approval applications with minimal guidance.
- Skill in interpreting and evaluating the impact of new regulations and advising senior management effectively.
- Proficiency in implementing and leading audit processes to ensure full regulatory compliance.
- Ability to work independently and drive projects to completion with strategic oversight.
- Ability to manage multiple project teams, demonstrating advanced project management skills.
- Strong people-management skills, with the ability to lead diverse teams in a regulatory environment.
- Advanced strategic advisory skills, including anticipating regulatory impacts and planning accordingly.
- Strong computer skills, including experience using artificial intelligence tools to monitor and summarize regulatory updates, draft impact assessments, support quality checks of submissions and lifecycle documents, refine language and ensure consistency, and streamline project tracking, including preparation of meeting minutes and action lists.
- Trusted and credible professional with proven ability to work under strict deadlines and multitask; strong communication skills; collaborative style; eager to learn and grow.
- Languages: English (Advanced), written and spoken; Russian.
Apply directly through our careers site:
https://wd3.myworkday.com/takeda/d/inst/15$392530/9925$440616.htmld
Locations
Minsk, Belarus
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
