Head of Legal & Compliance, Europe

Job title: Head of Legal & Compliance, Europe

Company: Krystal Biotech


Job description: Head of Legal & Compliance, EuropeAbout Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs.Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience.Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology.Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.Position Overview:We are seeking a Head of Legal & Compliance, Europe to establish and lead our legal and compliance function in the region. This hands-on role will be responsible for providing strategic legal counsel, ensuring regulatory and compliance adherence, and mitigating risks related to our European operations, with a primary focus on commercial, regulatory, corporate, and healthcare compliance matters. The role requires close collaboration with cross-functional teams and regulatory bodies to support Krystal Biotech’s growth and success in Europe.Responsibilities

• Serve as the primary legal advisor for Krystal Biotech’s European operations, providing counsel on corporate, commercial, regulatory, and healthcare compliance matters.
• Ensure the company’s European legal and compliance strategies align with business objectives and regulatory requirements.
• Develop and provide legal support for contract negotiations, distribution agreements, vendor relationships, and strategic partnerships.
• Advise on market access strategies, pricing, and reimbursement from a legal and compliance perspective.
• Oversee legal and compliance frameworks related to EU and country-specific pharmaceutical laws, regulations, and industry codes (e.g., EFPIA, GDPR, ABPI, French Transparency Laws).
• Develop, implement, and monitor compliance policies and training programs to ensure adherence to anti-bribery, anti-corruption, pharmacovigilance, promotional practices, and data privacy laws.
• Support interactions with regulatory authorities, health technology assessment (HTA) bodies, and other governing entities.
• Advise on corporate governance matters related to Krystal Biotech’s European subsidiaries and operations.
• Collaborate with business development, commercial, medical affairs, and HR teams on legal matters.
• Identify, assess, and mitigate legal risks affecting the company’s operations in Europe.
• Manage legal disputes, litigation, and enforcement matters in collaboration with external counsel.
• Provide legal support for internal investigations and compliance audits.

Qualifications & Experience

• Law degree (LLB, JD, or equivalent) with admission to practice in at least one European jurisdiction.
• 10+ years of legal experience in pharmaceutical, biotechnology, or life sciences sectors, including regulatory and compliance expertise.
• Strong understanding of EU pharmaceutical laws, corporate compliance, anti-corruption regulations (FCPA, UK Bribery Act), and GDPR.
• Experience advising on market access, pricing, and reimbursement strategies in Europe.
• Proven ability to develop and implement legal and compliance frameworks in a multinational environment.
• Excellent communication, negotiation, and stakeholder management skills.
• Fluency in English required; additional European languages are a plus.

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc.Privacy Policy:
Krystal Biotech collects your personal data to process your application and possibly offer you an employment contract. You have the right to access, rectify, erase, and obtain the portability of your personal data. Under certain conditions, you also have the right to restrict the processing and object to it. In order to reach out for new opportunities, and unless you object to it, this information will be kept for a maximum of 2 years if your application is unsuccessful. For more information on the use of your data and your rights, please consult our .Powered by JazzHR

Expected salary:

Location: Zug

Job date: Sun, 16 Mar 2025 04:43:32 GMT

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