Head Legal & Compliance Italy

Galderma is the emerging pureplay dermatology category leader present in approximately 90 countries. We deliver an innovative sciencebased portfolio of premium flagship brands and services that span the full spectrum of the fastgrowing dermatology market through Injectable Aesthetics Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981 we have dedicated our focus and passion to the human bodys largest organ the skin meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives we are advancing dermatology for every skin story.

We look for people who focus on getting results embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all they must be passionate about doing something meaningful for consumers patients and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company we embrace diversity and respect the dignity privacy and personal rights of every employee.

At Galderma we actively give our teams reasons to believe in our bold 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 companys 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 daytoday operations in a fastpaced dynamic environment. This individual will also have the opportunity to lead significant crossfunctional projects manage external legal relationships and shape the companys legal and compliance culture in Italy.

Key Responsibilities:

• Serve as the primary legal advisor to Galderma Italys leadership and business units.
• Provide legal guidance on the commercialization and launch of Galdermas 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 crossborder 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 industryspecific 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 resourcesrelated 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 Companys 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 inhouse) with a strong background in pharmaceutical biotechnology medical devices or consumer health sectors.
• Admission to the bar is preferred.
• Indepth 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 highpriority initiatives in a rapidly evolving business landscape.
• Excellent communication and interpersonal skills with the ability to influence and collaborate across teams.