Head of Legal & Compliance Europe
Head of Legal & Compliance Europe
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Position Summary
The Head of Legal & Compliance Europe is accountable for legal and compliance dealings for Acadias 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 Acadias 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 (SOPs) (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 Acadias 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).
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Required Experience:
Director
Employment Type
Full Time
