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Reporting to the General Counsel, the Corporate Counsel - Regulatory is responsible for handling a variety of healthcare-related legal, regulatory and compliance issues governing pharmaceutical products with a primary focus on laws and regulations relating to advertising and promotion; fraud; abuse; anti-trust; and for providing contractual/commercial support to the US organization as it prepares for its initial BLA submission and potential product launch.
Provide legal and business advice to Marketing, Sales, Medical Affairs and Regulatory Affairs departments concerning a broad range of legal, regulatory and compliance issues, including Food, Drug and Cosmetic Act, False Claims Act, Anti-Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, Foreign Corrupt Practices Act and competition law.
Analyze product labeling, promotional materials, marketing strategies, brand plans, salesforce initiatives, supply chain issues and business plans, advisory board proposals, speaker programs, medical education initiatives and external company communications/social media for legal risks and propose appropriate actions to secure compliance with relevant rules, regulations and policies.
Serve as a member of various cross-functional teams, including the MLR review committee, for DBV’s product candidates.
Prepare, review and negotiate commercial, 3rd party vendor, service, pharmacy, and consulting agreements and other corporate agreements as needed.
Counsel and support business and technology teams by providing advice on legal, contractual and privacy requirements related to websites, mobile applications, and similar initiatives
Regularly update clients on relevant legal developments in their areas of business.
Counsel and collaborate with the Compliance Department on policy interpretation, training, and other relevant activities.
Provide legal advice and assistance for the development of policies/training and conduct training.
J.D. required plus an active license to practice law in any state
5+ years of relevant experience within the life sciences industry
Expertise in corporate compliance and transactional experience is required, including strong contract drafting skills. Prior experience drafting and negotiating clinical research agreements, both sponsored and investigator initiated, is preferred
Ability to build consensus with diverse stakeholders and third parties, and form strong, collaborative working relationships with internal clients and external vendors/agencies
Excellent written and oral communication skills, including positive negotiation
Ability to travel domestically and internationally as needed
About DBV Technologies
DBV Technologies is developing Viaskin®, a proprietary technology platform with broad potential applications in immunotherapy. Viaskin is based on epicutaneous immunotherapy, or EPIT®, DBV’s method of delivering biologically active compounds to the immune system through intact skin. With this new class of self-administered and non-invasive product candidates, the Company is dedicated to safely transforming the care of food allergic patients, for whom there are no approved treatments.