Executive Director, Regulatory Advertising, Promotion & Labeling

You will be responsible for… • Responsible for driving development and life-cycle management of labeling • Responsible for the review, approval, and submission of US promotional materials • Ensure materials are accurate, truthful and not misleading, presented in a fair and balanced manner, consistent with product labeling, well-substantiated by current and scientifically valid evidence, adherent to applicable advertising and promotion standards, and comply with all internal and external policies and procedures • Build and maintain the systems to support timely and compliant reviews of ad/promo materials • Support regulatory strategy colleagues in preparing for and engaging with FDA in matters related to product labeling • Serve as a liaison with the FDA on issues related to advertising and promotional materials • Effectively communicate and manage potential regulatory issues and concerns with Senior Marketing, Promotional Review Team, Global Regulatory Affairs, and Medical Affairs • Drive promotional regulatory strategy in collaboration with Commercial, Promotional Review Team, Global Regulatory Liaisons, and Medical Affairs • Actively participate in product development meetings • Work independently and recognize when issues need to be elevated to Senior Management; implement, review and define standards for promotion, including traditional and emerging promotional platforms • Develop and implement departmental strategic initiatives; serve as resource to internal leadership on risk assessment for new Commercial initiatives • Engage in appropriate activities to improve the regulatory environment through Agency Contacts as appropriate • Enhance collaboration across the organization while developing and maintaining varied disciplines across multiple review committees • Provide mentoring and promotional regulatory training to team members as appropriate What Knowledge & Experience you'll bring to us... • BA/BS degree required in a health/life sciences or related field • A minimum of 10 years of regulatory ad/promo and labeling experience; oncology experience preferred • Direct and successful experience in Regulatory including NDA/BLA/MAA, lifecycle management, from the perspective of developing and implementing complex labeling strategies • Advanced working knowledge ad/promo/labeling regulations, guidance, and OPDP expectations • Strong strategic skills including demonstrated ability to make complex decisions and willingness to defend difficult positions • Demonstrated excellence in project management with a proven track record of effectively managing multiple projects/priorities simultaneously • Experience serving as the company's regulatory liaison to the FDA's Advertising and Promotional Labeling Branch and Office of Prescription Drug Promotion • Lead submissions of promotional material to FDA's Advertising and Promotional Labeling Branch and Office of Prescription Drug Promotion • Regulatory representative in promotional team reviews • Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment • Outstanding relationship-building skills, as well as influencing and negotiating skills • Excellent interpersonal skills with ability to lead, interact with, focus, resolve conflict, and drive consensus among individuals from a variety of cultures and disciplines • Significant track record in development of labeling and ad/promo materials in preparation for US Commercial launch as well as other markets • Proven experience in selection, implementation and use of the appropriate Regulatory ad/promo systems, vendors, and procedures • Self-motivated, flexible, innovative, able to prioritize and multitask while working in a fast-paced and demanding environment • Superior communication skills: oral, written, negotiation, and strong time-management • A critical and logical thinker with the ability to analyze problems, identify alternative solutions and implement recommendations for resolution • Strong knowledge of pharmaceutical development (CMC, Nonclinical, Clinical), with the ability to understand and interpret data/information and its practical application from a labeling and ad/promo perspective • Experience working with external consultants and contractors • Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives. What we have for you! Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees.