Head Legal & Compliance Italy

Galderma; Milano; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading dermatology company in Italy is seeking an experienced Head of Legal and Compliance. This role involves providing strategic legal counsel, ensuring compliance with regulations, and leading initiatives in a dynamic environment. Ideal candidates will have 10-15 years of experience in the pharmaceutical sector, with a strong track record in regulatory affairs and legal advice. The position offers the chance to shape compliance culture and drive key legal strategies.

Competenze

• Extensive experience in legal compliance and advisory roles.
• Proven track record in the pharmaceutical industry.
• Strong understanding of Health Italy regulations.

Mansioni

• Serve as the primary legal advisor to leadership.
• Provide guidance on the launch of new products.
• Support compliance training programs for staff.

Conoscenze

Legal expertise in pharmaceutical law

Risk management

Regulatory compliance knowledge

Contract negotiation

Project management

Interpersonal skills

Formazione

10-15 years of legal experience in relevant sectors

Bar admission preferred

Descrizione del lavoro

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 shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning, and bring positive energy. They must combine initiative with teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and healthcare professionals. We aim to empower each employee and promote 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 opportunity to gain new and challenging 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 adherence 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 environment. This individual will also lead cross-functional projects, manage external legal relationships, and shape the company’s legal and compliance culture in Italy.

Key Responsibilities :

1. Serve as the primary legal advisor to Galderma Italy’s leadership and business units.
2. 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 authorities and stakeholders.
3. Advise on strategies for launching new aesthetic products or services, ensuring all promotional and commercial efforts meet legal, ethical, and regulatory requirements.
4. Offer counsel on marketing and sales, including digital campaigns.
5. Support review, approval, and documentation for local HCP / HCO engagement and cross-border activities following relevant policies and laws.
6. Advise senior management on regulatory compliance, competition law, product liability, and contract negotiations, including distribution agreements.
7. Lead efforts to ensure compliance with all Health Italy regulations, applicable laws, and industry standards.
8. Develop and deliver compliance training programs for staff at all levels, ensuring understanding of legal risks and obligations.
9. Localize global Policies and Codes, ensuring local adoption, training, and approval of local SOPs.
10. Perform local risk assessments and active mitigation planning.
11. Lead and manage dispute resolution, including legal and HR-related matters.
12. Act as contact point for industry associations on legal and compliance matters.
13. Provide legal advice related to Legislative Decree 231/2001 upon request of the supervisory body.
14. Coordinate during Global Internal Audits, industry association audits, and authority dawn raids.
15. Collaborate with departments like finance, HR, and operations for a cohesive compliance approach.

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

Skills & Competencies :

1. At least 10-15 years of legal experience in pharmaceutical, biotech, medical devices, or consumer health sectors.
2. Bar admission preferred.
3. In-depth knowledge of Health Italy regulations, industry standards, and best practices.
4. Proven track record in advising on commercial launches, especially in pharmaceuticals or medical devices.
5. Experience with biologic products and navigating regulatory pathways is highly preferred.
6. Strong in risk management, compliance programs, and legal contract negotiations.
7. Ability to advise senior management on complex legal issues with an entrepreneurial and agile approach.
8. Strong project management skills and ability to lead high-priority initiatives.
9. Excellent communication and interpersonal skills for effective collaboration.