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Carrot Peelers, Sales, Personality and Your Job Search
In-House
Attorney
Health Care
Litigation - Whistleblower - CFTC
Min 10 yrs required
Head of Regulatory Law and GBU Support The candidate will support reports to the North America General Counsel. Will work on managing a team of approximately 15 lawyers, paraprofessionals and staff that focus on the following practice areas of US law: FDA and other Regulatory Laws pertinent to biopharmaceuticals. Serve on the NA Legal Leadership team and interact closely with other Senior Sanofi legal leaders that help support and advise the NA General Counsel. Responsible for interacting with and advising senior business leaders in the US concerning legal issues that have a direct effect on the success of the company. Predominately one of management, consultation, strategy, advising and influencing. Responsible for providing legal advice, counsel and services that ensure the organization is operating in compliance with regulations and that regulatory reporting requirements are met including responding to questions from the business and regulatory agencies. Serve as a recognized thought leader within and outside of Sanofi in the legal-regulatory area. Coordinate strategy at a high level to help ensure regulatory goals are met. Provide expert advice and counsel to businesses concerning complex legal-regulatory matters and issues pertaining to the business. Advise senior management concerning legal-regulatory matters that have widespread impact Responsible for regulatory counsel activities: including, but not limited to interactions with Food and Drug Administration (FDA) and State and federal healthcare agencies. Works closely with Corporate Affairs, Regulatory Affairs and with various leadership teams on issues of regulatory policy, including FDA reform legislation, data exclusivity issues and labeling issues. Represents the Company on various industry trade association and intra-industry legal initiatives focused on regulatory issues. Provides support on contracting, strategic initiatives and other issues that Medical and Regulatory Affairs undertake. Manages the team who is reviewing advertising and promotional materials, disease awareness materials, training materials, speakers bureau programs, medical education initiatives, advisory board proposals, market research materials, grants, and sponsorships and charitable donation proposals. Ensuring workload distribution amongst team is managed in way that allows for business flexibility, launch support and cross-functional development. Complete responsibility for leading this group related to performance expectations, workload allocation, employee relations, performance management, development and training needs. Counseling, advising and training internal client teams on a variety of matters and projects to help ensure compliance with applicable laws and regulations and company policies and procedures, including the company’s Corporate Integrity Agreement; analyzing annual budgeting plans and business rationale forms; working collaboratively with other members of the department in support of business development and alliance management activities related to the business.
Qualification and Experience
The candidate should have excellent academic credentials, including a J.D. Degree from a highly respected law school, with 10+ years of post-J.D. experience, ideally including training in a law firm, combined with corporate experience (although corporate experience is preferred. Agency (FDA) experience highly desired. Should have 10+ years of experience working in private practice and in-house; experience with counseling senior business leaders; and a good understanding of the business and legal challenges and opportunities of the biopharmaceutical industry is essential. Solid working knowledge of legislative and regulatory process is essential. Knowledge of FDA drug and medical device requirements and submission process is essential. Knowledge of FDA promotional, advertising and labeling requirements for drugs is essential. Working knowledge of US Federal and state healthcare compliance considerations, including without limitation the False Claims Act, the Anti-Kickback Statute, the Transparency Provisions of the Patient Protection and Affordable Care Act (the “Sunshine Actâ€), and US Federal healthcare program requirements under the Food, Drug and Cosmetic Act (“FDCAâ€) is essential. Prior experience as a member of an in-house legal department at a biotechnology or pharmaceuticals company is strongly preferred. Experience with ‘C-level’ executives, and advising executives, partnering with heads of businesses, and working with sophisticated leaders is strongly preferred. Excellent communication, interpersonal, and writing skills is essential. Should be experienced healthcare attorney with industry and or agency (FDA) experience.
Ref POS_75131556-1
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