Global Regulatory Affairs Senior Manager

Jefferson Wells; Milano; In loco; EUR 80.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading regulatory consulting firm in the Milan area seeks a Regulatory Affairs Senior Manager. The role involves developing and implementing regulatory strategies for product approval, engaging with health authorities, and leading cross-functional teams. Strong leadership and regulatory compliance skills are essential. This position is office-based and offers a dynamic environment for experienced professionals.

Competenze

• Extensive experience in developing and executing global regulatory strategies.
• Proven ability to manage complex submissions and engage with health authorities.
• Strong understanding of evolving regulatory landscapes.

Mansioni

• Develop and implement regulatory strategy for products.
• Ensure rapid approval with advantageous labelling.
• Lead regulatory milestones and risk mitigation activities.

Conoscenze

Leadership in cross-functional teams

Risk assessment

Regulatory compliance

Engagement with health authorities

Management of complex submissions

Descrizione del lavoro

The Regulatory Affairs 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.
• Partner with marketing company and regional regulatory affairs staff to influence developing views / guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally.
• Define the regulatory development plan and own the planning and construction of the global dossier and core prescribing information.
• Lead the regulatory staff working on a product / project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality.
• 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.