Takeda
Healthcare
RegulatoryAffairsLead,Belarus
“Regulatory Affairs Lead, Belarus at Takeda. Skills: Regulatory affairs, Regulatory strategy, Product registration, Lifecycle management. Lead regulatory function in Belarus. Drive national regulatory strategy”
What You'll Achieve.
Deliver on-time product registrations; Ensure uninterrupted supply; Ensure patient access; Secure approval; Maintain lifecycle maintenance; Ensure regulatory compliance; Meet expected RA timelines; Meet RA KPIs; Deliver product approvals; Faster access to innovative medicines; Ensure GMP certificates
Industry & Context.
Interpreting regulations; Evaluating regulatory impact; Risk management
What They're Looking For.
Must Have
Higher education (medical, pharmaceutical, chemical, or biological degree), At least 5 years of relevant experience, Proven leadership skills, Knowledge of local pharmaceutical market legislation, Knowledge of Belarus/EAEU regulatory framework, Experience in registration of medicines, Experience in registration of pharmaceutical substances, Experience in registration of medical devices, Experience preparing regulatory dossiers/submissions, Experience interacting with health authorities, Experience representing organization with regulatory bodies, Manage and file complex product notifications, Manage and file approval applications, Interpret and evaluate impact of new regulations, Advise senior management effectively, Implement and lead audit processes, Ensure full regulatory compliance, Work independently, Drive projects to completion, Manage multiple project teams, Advanced project management skills, People-management skills, Lead diverse teams, Advanced strategic advisory skills, Anticipate regulatory impacts, Plan regulatory impacts, Computer skills, Experience using AI tools, Trusted and credible professional, Work under strict deadlines, English (Advanced), Russian language proficiency
What You'll Do.
Lead regulatory function in Belarus
Drive national regulatory strategy
Drive EAEU regulatory strategy
Ensure product availability
Ensure business continuity
Deliver on-time product registrations
Manage lifecycle maintenance
Submit for timely approvals
Maintain engagement with Health Authority
Ensure import batch testing
Ensure product certification
Align regulatory strategy
Ensure compliance with legislation
Ensure compliance with regulations
Prepare optimal regulatory strategies
Execute optimal regulatory strategies
Deliver product approvals
Manage product lifecycle
Develop relationships with local commercial organization
Develop relationships with distributors
Develop relationships with cross functional teams
Develop relationships with service providers
Develop Belarus/EAEU regulatory strategy
Execute Belarus/EAEU regulatory strategy
Submit medical devices
Submit other relevant products
Implement state registration procedure
Manage state registration renewal
Manage submission variations
Manage approval variations
Liaise with EAEU Registration Group
Agree on registration dossier information
Determine registration strategy
Determine registration procedures
Formulate budget for drugs
Control timely fulfillment of deadlines
Maintain up-to-date information
Supervise packaging material development
Supervise packaging material coordination
Supervise packaging material approval
Supervise checking medical information
Supervise approving medical information
Supervise checking promotional information
Supervise approving promotional information
Provide monthly report on registration status
Follow up with local HA
Secure uninterrupted access to therapy
Provide expert regulatory guidance
Support cross-functional projects
Coordinate GMP application submissions
Coordinate GMP inspections
Oversee work instructions
Conduct regular self-inspections
Manage regulatory risk
Maintain relevance of SOPs
Develop schedule for SOP revision
Monitor regulatory legislation
Ensure compliance with Belarus/EAEU legislation
Ensure compliance with Company policies
Ensure compliance with ethical business practices
Manage and develop RA team
Enhance team capabilities
Create effective team
Ensure effective team work
Analyze performance of subordinate employees
Adjust subordinate tasks
Monitor implementation of goals
Monitor implementation of objectives
Provide conditions for professional development
Familiarize employees with changes
Participate in selection of new employees
Ensure delivery of regulatory KPIs
Perform individual tasks
Perform instructions of immediate supervisor
How You'll Work.
Team & Collaboration
Cross functional team; Local commercial organization; Distributors; Service providers; EAEU Registration Group; Market access functions; Medical affairs functions; Patient access functions; Takeda and partner manufacturing sites
Communication Scope
Strategic advisory; Reporting
Process & Methodology
Advanced project management, Manage multiple project teams, Drive projects to completion
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