Senior Regulatory Affairs Manager

Contract type:

Permanent

Bracco is an international Group active in the healthcare sector and a leader in diagnostic imaging. The Group’s main products are contrast agents sold in over 100 countries, both directly and indirectly through branches, joint ventures and license and distribution agreements.

The Senior Regulatory Affairs Manager leads and coordinates all activities required to achieve and maintain the registration of assigned products in compliance with applicable regulations and business objectives. This role encompasses managing regulatory submissions, engaging with health authorities, accelerating approval timelines, and ensuring ongoing regulatory compliance.Key Activities and Responsibilities

• Serve as the primary contact with external regulatory authorities, contributing to regulatory strategy, facilitating timely approvals, and resolving regulatory issues effectively.

• Collaborate with global and regional colleagues to develop and author regional regulatory strategies aligned with business objectives.

• Ensure execution of critical regulatory deliverables in accordance with global regulatory strategy and planning, working cross-functionally to support product development plans.

• Identify and assess regulatory risks associated with product development and define appropriate mitigation strategies.

• Advise on global Clinical Trial Application (CTA) submission strategy and provide regulatory guidance throughout the research and development lifecycle.

• Lead regulatory activities for assigned projects and represent the regulatory function within cross-functional project teams.

• Develop and execute regulatory strategy and submission plans, or oversee delegated activities performed by external vendors.

• Support market access initiatives by ensuring regulatory documentation is aligned with value and access requirements.

• Monitor evolving regulatory requirements and trends across relevant regions, providing expert guidance to development teams and governance bodies.

• Ensure submissions meet the highest standards of scientific accuracy, regulatory compliance, and best practice presentation.

• Proactively plan and manage submissions to agreed timelines.

• Identify regulatory challenges and drive effective solutions.

• Engage with regulatory authorities to facilitate efficient review and approval processes.

Education & Experience

• Degree in Life Sciences or related scientific discipline.

• Strong working knowledge of regulatory requirements across major regions (e.g., US, EU, ROW, APAC) relevant to assigned projects.

• Demonstrated experience interfacing directly with major regulatory authorities (e.g., FDA, EMA, PMDA).

• Proven ability to independently manage assigned projects while mentoring and guiding less experienced regulatory professionals.

• Experience contributing to complex and cross-regional regulatory programs.

• Strong analytical skills with the ability to interpret, summarize, and communicate complex scientific data clearly in high-quality written and verbal formats.

• Excellent interpersonal and stakeholder management skills, with the ability to build effective working relationships internally and externally.

• Strong customer focus, with demonstrated accountability in meeting commitments and deadlines.

• Collaborative team player with the ability to work effectively in cross-functional environments.

• Flexibility to support global regulatory activities, including occasional international travel as required.

If you meet the requirements of this opportunity and would like to join an international group working to improve patients' lives, apply now!

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