Head of Legal and Compliance Italy

Posted 10 Days Ago
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Milano, ITA
In-Office
Expert/Leader
Pharmaceutical • Manufacturing
The Role
The Head of Legal and Compliance acts as the primary advisor for Galderma in Italy, ensuring adherence to legal and regulatory standards while supporting various business units and stakeholders, leading compliance initiatives and managing legal disputes.
Summary Generated by Built In

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing 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 body's 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.

The Head of Legal and Compliance supports Galderma 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.

Job Title: Head of Legal and Compliance Italy

Location: Milan , Italy - hybrid

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 advice 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 dawn raids.
  • 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 required.
  • 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.

Skills Required

  • 10-15 years of legal experience in pharmaceutical, biotechnology, medical devices or consumer health sectors
  • Admission to the bar
  • In-depth knowledge of Health Italy regulations
  • Significant experience in risk management and compliance program development
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The Company
HQ: Dallas, TX
5,930 Employees

What We Do

Galderma is the leading company solely dedicated to skin and advancing the future of dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Through trusted partnerships with healthcare professionals, we ensure to meet individual consumer and patient needs with superior outcomes.

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