On behalf of a multinational pharma group, Jefferdon Wells is looking for a
Global Regulatory Affairs Senior Manager
The Global RA Senior Manager is accountable for the development and implementation of the regulatory strategy for a product/group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
The role requires extensive experience in developing and executing global regulatory strategies to ensure timely approvals and favorable labeling aligned with product characteristics and business needs. The ideal candidate will demonstrate strong leadership in cross-functional teams, risk assessment, and regulatory compliance throughout the product lifecycle. Proven ability to engage with health authorities, manage complex submissions, and stay ahead of evolving regulatory landscapes is essential. Main responsibilities:
* Accountable for the development and implementation of the regulatory strategy for a product/ group of products, and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labelling in keeping with the properties of the product(s) and the needs identified by the business, and patients.
* Working with the appropriate GPROC and local functions accountable for product maintenance, supply and compliance activities associated with marketed brands.
* Accountable for the delivery of all regulatory milestones including assessment of the approvability of the program together with risk mitigation measures.
* Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
* Define the regulatory development plan and own the planning and construction of the global dossier and core prescribing information.
* Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project.
* Provide regulatory leadership as needed in product license-in/due diligence review, product divestment and product withdrawal.
The position is office-based, HQ in Milan area.
Company
Multinational group focused on the production of high-quality medicinal specialties adhering to the highest quality standard in different therapeutic areas (cv, gastro, gyn, immunology, rare diseases).
Requirements:
Scientific Degree, consolidated experience in RA roles within pharma multinational companies or CRO, leadership, excellent knowledge of regulatory processes at European / Global level, excellent knowledge of regulations, strong understanding of global lifecycle management dynamics, english fluent
Economic conditions:
Interesting base salary + bonus + benefits
Permanent role