Head Legal & Compliance Italy

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else.

At Galderma, we actively give our teams reasons to believe in our ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Galderma Italy is seeking an experienced and dynamic Head of Legal and Compliance to support its three core business units: Prescription Medicines, Aesthetics, and Dermatological Skincare. This multifaceted role is critical in ensuring the organization adheres to legal, compliance, and ethical standards while safeguarding the company's reputation and integrity. The Head of Legal and Compliance will work closely with business leaders, providing strategic legal counsel and driving key initiatives, regulatory matters, and day-to-day operations in a fast-paced, dynamic environment. This individual will also have the opportunity to lead significant cross-functional projects, manage external legal relationships, and shape the company’s legal and compliance culture in Italy.

Key Responsibilities:

• Serve as the primary legal advisor to Galderma Italy’s leadership and business units.
• Provide legal guidance on the commercialization and launch of Galderma’s first biologic product, ensuring regulatory compliance and supporting business strategy and negotiations with relevant national and regional authorities and stakeholders.
• Advise on strategies for launching new aesthetic products or services, ensuring that all promotional and commercial efforts meet legal, ethical, and regulatory requirements.
• Offer counsel on key aspects of marketing and sales, including digital campaigns.
• Support review, approval and documentation for local HCP/HCO engagement and cross-border activities following relevant policies and procedures, and applicable laws.
• Advise senior management on matters related to regulatory compliance issues, competition law, product liability, and contract negotiations, including distribution agreements.
• Lead efforts to ensure compliance with all Health Italy regulations, applicable laws, and industry-specific standards.
• Lead the development and delivery of compliance training programs for staff at all levels, ensuring understanding of legal risks, obligations, and best practices.
• Localize global Policies and Codes (ensuring local adoption, training and, where applicable, drafting and approving local SOPs).
• Perform local risk assessment and monitoring activities, actively working on mitigation plan.
• Lead and manage the resolution of disputes across the organization, including both legal and human resources-related matters.
• Act as industry associations contact point, for legal and compliance matters.
• Provide legal advices related to Legislative Decree 231/2001 upon request of the supervisory body (the so called Organismo di Vigilanza).
• Act as local coordinator during Global Internal Audit, industry association audit (e.g. Farmindustria/Certiquality annual audits) and potential Authority dawnraids.
• Work with various departments, including finance, HR, and operations, to ensure a cohesive approach to compliance.

In close collaboration with local stakeholders, execute global policies and procedures through the Company’s Data Privacy Management System and drive global training and awareness campaigns.

Skills & Competencies:

• At least 10 -15 years of legal experience (private practice and/or in-house), with a strong background in pharmaceutical, biotechnology, medical devices or consumer health sectors.
• Admission to the bar is preferred.
• In-depth knowledge of Health Italy regulations, industry standards, and best practices.
• Proven track record in advising on commercial launches, preferably in the pharmaceutical and/or medical devices sector.
• Experience with biologic products, including navigating complex regulatory pathways for their approval and commercialization, is highly preferred.
• Significant experience in risk management, compliance program development, and legal contract negotiations.
• Proven ability to advise senior management and business units on complex legal issues, with a focus on entrepreneurship and agility.
• Strong project management skills with the ability to lead high-priority initiatives in a rapidly evolving business landscape.
• Excellent communication and interpersonal skills, with the ability to influence and collaborate across teams.