Regulatory Affairs Manager Ii

hace 2 semanas

Barcelona, España Astrazeneca Gmbh A tiempo completo

Job Title: Regulatory Affairs Manager II Career Level - D Introduction to role Are you ready to play a pivotal role in gaining approval for our novel work on unmet medical needs? As a Regulatory Affairs Manager II, you will be a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will work flexibly within a Global Regulatory Execution Team (GRET) to manage regulatory affairs, global labeling, and dossier management. This role requires proficiency in applying established standards and the ability to lead cross-functional activities, contributing to the continuous improvement of processes and tools.
Accountabilities Regulatory Affairs ManagementUnderstands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.Provides regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).Uses and shares best practices during interactions with health authorities and in day-to-day work.Leads and/or contributes to the planning, preparation, and delivery of regulatory maintenance submissions.Liaises closely with cross-functional members with aligned product responsibilities.Develops, executes, and maintains submission delivery plans and proactively provides status updates to stakeholders.Identifies regulatory risks and proposes mitigations to Lead RPM and cross-functional teams.Supports operational and compliance activities for assigned deliverables.Provides coaching, mentoring, and knowledge sharing within the regulatory organization.Contributes to process improvement.Global Labelling ManagementMaintains core labeling documents including the Core Data Sheet and Core Patient Information Leaflet.Ensures consistency with applicable core labeling documents and internal standards.Ensures updates to core texts are completed and communicated to Marketing Companies (MCs) in a timely manner.Maintains repositories of current regional labeling and ensures proper version control.Dossier ManagementContributes proactively to resourcing submission deliverables through liaison with internal Global Regulatory Operations or outsourcing partners.Leads the dossier management deliverables for divestment of products.Identifies potential regulatory risks to operational plans and proposes options to mitigate risks.Plans and manages publishing deliverables, as well as associated lifecycle and license information.Develops and maintains strong partnerships with internal and external customers and partners.Essential Skills/Experience Relevant University Degree in Science or related discipline.Minimum 8 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling, and publishing, and of working in regulated markets.Thorough knowledge of the regulatory product maintenance process.Strong project management skills.Leadership skills, including experience leading multi-disciplinary project teams.Desirable Skills/Experience Regulatory affairs experience across a broad range of markets.Managed regulatory deliverables at the project level.Experience of working with people from locations outside of India, especially Europe and/or USA.Excellent English written and verbal communication skills.Cultural awareness.Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions.Proficiency with common project management (e.g., MS Project) and document management tools.Ability to work independently and as part of a team.Influencing and stakeholder management skills.Ability to analyze problems and recommend actions.Continuous Improvement and knowledge sharing focused.Ready to make a difference? Apply now

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  • Regulatory Affairs Manager Ii

    hace 2 semanas

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    .Job Title: Regulatory Affairs Manager II Career Level - D Introduction to role Are you ready to play a pivotal role in gaining approval for our novel work on unmet medical needs? As a Regulatory Affairs Manager II, you will be a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and...

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