Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Lead Counsel, Head of Regulatory Compliance
At Thermo Fisher Scientific, we are dedicated to creating positive, global impact. Join our team to help bring our mission to life by enabling customers to contribute to a healthier, cleaner, and safer world. We provide our employees with the resources to pursue their career goals while advancing scientific progress through research, development, and the delivery of life-changing therapies. With clinical trials spanning over 100 countries and the development of novel frameworks for clinical research, our work integrates laboratory, digital, and decentralized clinical trial services. Your commitment to excellence will directly contribute to improving health outcomes for people and communities, both now and in the future.
Position Overview:
As the Lead Counsel and Head of Regulatory Compliance, you will oversee the global Regulatory Compliance Legal function for Pharma Services Group (PSG) and act as the lead counsel and strategic advisor to the PSG Quality team. You will collaborate with PSG Strategy and Development teams, as well as senior leadership, on mergers and acquisitions (M&A) and strategic investment initiatives.
Key Responsibilities:
Lead legal counsel on a wide range of regulatory, compliance, and legal matters within the pharmaceutical clinical and commercial services space, with a focus on FDA regulations, cGMP, and GCP compliance.
Partner with Thermo Fisher's Chief Compliance Officer and key compliance leaders in areas such as Quality, Audit, EH&S, Finance, Internal Audit, and IT to design, develop, and implement Thermo Fisher's Corporate Compliance Program.
Provide expert guidance to PSG leadership on compliance issues related to FDA and international regulatory bodies.
Establish and enforce compliance standards and procedures across PSG, including areas like anti-bribery, Sunshine Act, and SecureMate vendor clearance. Lead compliance initiatives, including training, communications, and cross-functional projects, serving as a liaison with Corporate Compliance and implementing core PSG initiatives.
Provide legal oversight for PSG's global trade compliance team. Collaborate with PSG General Counsel, the Strategy team, and Corporate Development leadership on M&A opportunities, ensuring legal and regulatory alignment throughout the transaction lifecycle.
Advise on M&A strategy, portfolio objectives, and participate in a variety of M&A activities from initial discussions to transaction closings and integration efforts.
Support Corporate Development and senior leadership on due diligence, deal structuring, contract negotiations, and managing stakeholder expectations. Work with cross-functional teams (Finance, Tax, IP, HR, Regulatory, EH&S, Risk) and external advisors (legal counsel, audit firms, investment banks) to ensure thorough diligence and compliance during M&A transactions. Drive continuous improvement initiatives to enhance operational efficiency, quality, and productivity.
Education:
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