Descrizione:
Experteer Overview
In this role you lead regional regulatory strategy and its execution for assigned assets, aligning with global goals while meeting regional regulations. You act as the single regional contact to coordinate GRLs, LOC RA, Medical and Commercial Leads to ensure timely, compliant submissions and cross-regional alignment. You will shape development plans across multiyear horizons and enable efficient decision-making through strong stakeholder collaboration. This is an opportunity to influence drug and vaccine regulatory pathways at scale within a purpose-driven biopharma company.
Retribuzione / Benefits
Lead development and execution of regional regulatory strategy for assigned assets, aligned with global strategy and regional requirements
Serve as the regional single point of contact for regulatory, ensuring alignment with GRLs, local teams and cross-functional stakeholders
Provide regulatory insights to anticipate risks, identify opportunities, and support decision-making
Drive submission and approval delivery across the region ensuring timely, compliant execution
Collaborate with global and local teams to integrate regional requirements into development plans (clinical, GMP, submission strategies)
Communicate regulatory plans, milestones, risks and implications clearly to stakeholders
Support continuous improvement, innovation, and knowledge sharing across regulatory teams
Responsabilità
Bachelor's Degree in Biological or Healthcare Science
Strong experience in regional regulatory strategy, submissions, and approvals
Knowledge of clinical development, regulatory requirements, and agency processes
Ability to work cross-functionally and influence stakeholders in a matrix environment
Strong decision-making and problem-solving skills with ability to assess regulatory impact
Proven ability to manage complexity, anticipate risks, and drive solutions
Digital fluency and ability to leverage tools to enhance delivery and efficiency
Requisiti fondamentali
competitive salary
annual bonus based on company performance
healthcare and wellbeing programmes
pension plan membership
shares and savings programme
hybrid working model
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