About Us
Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products.
With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally.
At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, and we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply our full potential.
About the Role
Reporting to the General Counsel, the Legal & Compliance Lead, International will serve as the senior legal and compliance leader for the Company’s direct operations in Ireland, the UK, Germany and Portugal, as well as other countries outside of the U.S. Where the Company does business. This position provides strategic legal and compliance advice to European business leaders, ensures compliance with applicable laws, and manages complex legal matters. This role is responsible for overseeing all European employment-related matters, enterprise risk management, anti-bribery and anti-corruption compliance (including FCPA), data privacy and GDPR compliance, sanctions compliance, commercial contracting, and broader regulatory compliance issues affecting the Company’s international business. The role partners closely with Commercial, Medical Affairs, Market Access, Regulatory Affairs, Clinical, Manufacturing, and HR teams to enable compliant growth across Europe and other countries where the Company does business.
The Legal and Compliance Lead, International is based in the UK office (Hook) and works onsite three days per week.
Key Responsibilities
Healthcare Regulatory & Compliance Leadership
- Ensure compliance with European and other international pharmaceutical and medical device regulations (including EMA frameworks and local competent authority requirements).
- Oversee compliance with industry codes (e.g., EFPIA Code, MedTech Europe Code, and local transparency rules).
- Provide legal support for promotional review processes, interactions with healthcare professionals (HCPs), advisory boards, grants, sponsorships, and congress activities.
- Advise on market access, pricing, reimbursement, government interactions, and anti-competition regulations.
- Support clinical trial and post-marketing research activities.
- Promote a culture of ethics and integrity across European operations.
Employment & Labor Law
- Lead all employment-related legal matters across international jurisdictions.
- Advise on hiring, terminations, restructuring, workforce reductions, works councils, collective bargaining, and cross-border employment issues.
- Manage employment disputes, investigations, and litigation across international jurisdictions.
- Partner with HR to ensure compliant employment policies and procedures.
Risk Management & Corporate Governance
- Develop and oversee risk management frameworks aligned with global standards (eg. U.S. Foreign Corrupt Practices Act (FCPA) and the UK Bribery Act).
- Identify, assess, and mitigate legal and compliance risks across the international business.
- Design and implement policies, controls, training, and monitoring programs in consultation with the Company’s Chief Compliance Officer.
- Oversee third-party due diligence and investigations in the international regions.
- Manage internal investigations and coordinate with regulators where necessary.
- Manage and oversee corporate governance and compliance for the ex-U.S. Legal entities (other than India), in consultation with the global corporate secretary.
Data Privacy / GDPR / Cybersecurity
- Oversee compliance with the General Data Protection Regulation (GDPR) and applicable international and country-specific data protection laws.
- Partner with IT and security teams on data governance, cybersecurity, breach response, and cross-border data transfers.
- Serve as key legal advisor on privacy-by-design initiatives and data processing agreements.
- Supervise or partner with the Data Protection Officer (DPO), as applicable.
- Provide training and raise awareness on data privacy issues and cybersecurity among employees and stakeholders based ex-US.
Commercial Contracting
- Assist with review of commercial agreements for the international business, in coordination with the Head of Commercial Contracts.
- Ensure contractual risk is appropriately assessed and mitigated.
Requirements
- Juris Doctor (JD) or equivalent European law degree from a recognized university; qualified to practice in at least one European jurisdiction.
- 12+ years of relevant legal experience in a combination of law firms and in-house roles, with a preference for experience in the pharmaceutical industry.
- Experience managing cross-border legal and regulatory issues internationally, with a focus on major European countries where the Company operates.
- Strong background in HCP engagement compliance and promotional review.
- Strong commercial acumen and ability to balance legal risk with business objectives.
- Experience interacting with regulators and government authorities preferred.
- Excellent communication skills and executive presence.
- Fluency in English required; additional EU language(s)preferred.
The base salary range for this position is $£145,000- £185,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term and long term incentive program based on performance and company results.
ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.