Head of Legal & Compliance Europe

Acadia Pharmaceuticals; Zug; Hybrid; CHF 150’000 - 200’000; Vollzeit

Zusammenfassung

A leading company in neuroscience is seeking a Head of Legal & Compliance for Europe. This role involves overseeing legal and compliance matters across various operations, providing expertise in pharmaceutical regulations, and ensuring adherence to ethical frameworks. The ideal candidate will have extensive experience in the biotech industry and strong leadership skills.

Qualifikationen

• 10 years of experience in pharmaceutical biotech, 5 years in leadership.
• Fluent in English and German; additional languages advantageous.

Aufgaben

• Legal and compliance business partner for regional operations.
• Responsible for reviewing and approving commercial and medical materials.
• Lead for regional compliance policies and training.

Kenntnisse

Analytical

Problem Solving

Project Management

Stakeholder Management

Leadership

Ausbildung

Masters of Law

MBA

Jobbeschreibung

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis, and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visitAcadia.comand follow us onLinkedInandX.

Position Summary

The Head of Legal & Compliance, Europe is accountable for legal and compliance dealings for Acadia’s proceedings and legal entities across Europe. The role provides expertise in pharmaceutical regulations and guidance at both the European and local country levels. Accountabilities include operating as legal and compliance lead on commercial, medical affairs, data protection and labor relations issues (in collaboration with People & Performance (P&P). The position also reviews, approves, and provides risk-intelligent advice on promotional and non-promotional materials and activities.

Primary Responsibilities

General

• Legal and compliance business partner to all Acadia’s regional business and country specific business operations.
• Contract lead for Commercial and Medical Affairs activities and support for Supply Chain/CDMO, R&D, frameworks and external manufacturing, including regional service agreements (vendors).
• Accountable for ethical frameworks, including regional and relevant country policies and Standard Operating Procedures (SOP’s) (in conjunction with Regulatory and Compliance).
• Ethics lead and co-lead with P&P for regional labor relations resolution and investigations.
• Regional privacy and data compliance lead (in conjunction with external Data Protection Officer and Data Privacy Representative).
• Lead for regional compliance policies and responsible for monitoring and training of corporate and regional policies, e.g., Code of Business Conduct.
• Regional point of contact for Compliance Hotline and corporate governance framework.
• Advisor on Merger &Acquisition transactions (where appropriate).
• Advise on and participate in corporate governance matters related to Acadia’s European subsidiaries and operations.
• Coordinator and budget management of spend for external counsel and service providers to the areas of accountability above.
• Act as (interim) country legal responsible person.
• Other duties as assigned.

Material Review and Approval

• Responsible for providing legal and compliance counsel, including reviewing and approving commercial and medical affairs materials and activities, including congress materials, e.g., symposia and booth content.
• Review and approve regional and country Expanded Access Program (EAP) materials.

Education/Experience/Skills

Masters of Law or equivalent legal degree; an additional commercial MBA or similar is considered an advantage. German Bar exam strong advantage. Targeting 10 years of experience in pharmaceutical biotech, with at least 5 years in a leadership role. Expertise with biotech and pharma regulations across Europe and at local country level.

Key Skills:

• Working knowledge with early access and reimbursement for European markets (EU and non).
• Full appreciation of finance (P&L, budgets, instruments), tax (transfer price optimization) and commercial law as well as licensing.
• Experience with European litigation and mediation.
• Knowledge of European healthcare systems, preferably in specialty pharmaceuticals.
• Strong understanding of European GDP regulations, FMD requirements, and pharmaceutical supply chain requirements
• Excellent analytical and problem-solving capabilities.
• Strong project management skills with track record of successful implementations.
• Fluent in English and German; additional European languages are advantageous.
• Excellent communication and stakeholder management skills
• Proven leadership abilities with experience influencing and guiding cross-functional teams.
• Ability to work effectively in a fast-paced, growing organization.
• Ability to travel to the US and other countries in Europe (EU and other).

#LI-HYBRID

EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn’t exactly what we describe here.

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