The Associate Director/Manager/Sr Manager/Director, Advertising and Promotion will provide strategic support to the review of Advertising and Promotion materials to meet the US brand team’s objectives while ensuring the necessary level of regulatory compliance. Responsibilities Ensure business compliance and implementation of and adherence to regulatory standards. Regulatory review of any internal and external business communications; includes NY support for Sales and Marketing initiatives and programs. Engage in appropriate activities to improve the regulatory environment through Agency contacts: Office of Prescription Drug Promotion (OPDP) and trade associations as appropriate. Mentor newer staff members across varied disciplines across multiple review committees. Enhance collaboration across a matrixed organization while developing and maintaining constructive relationships. Ability to work independently and to recognize when issues need to be elevated to Senior Management. While working in a highly matrix environment, apply critical review skills and creative solutions to diverse promotional scenarios. Ability to work in a team dynamic. Ability to perform detailed work; ensure consistency within department and across BUs through knowledge sharing. About you Technical Skill Requirements Demonstrable experience of effective delivery in complex matrix environment. Strong negotiation and communication skills. Level of the selected candidate will be determined based upon multiple factors including relevant education, overall experience, and prior track record. Qualifications A bachelor's degree (or equivalent) and relevant industry experience is required. A degree in a scientific discipline is strongly preferred. A minimum of 7 years of experience in Regulatory Affairs with significant Subject Matter Expertise in AdPromo. Exceptional communication, negotiation, and partnering skills are a must. Experience reading, understanding, and applying regulations to constantly changing environments. Ability to independently develop a course of action leading to a beneficial outcome. Strong knowledge and interest in the evolving landscape within regulatory guidance in reference to AdPromo regulations. Demonstrated ability to identify emerging issues and initiate actions to recommend solutions, including in areas of ambiguity. This individual must demonstrate a high level of self-awareness and adaptability. Must be resilient, willing to learn from others, flexible and adaptable. Occasional travel to major medical meetings and conventions to monitor competitive activities and audit company-sponsored promotional exhibits and activities, as appropriate. 7 years or greater regulatory experience including significant Advertising & Promotion expertise; launch experience a plus. #J-18808-Ljbffr
Regulatory Manager
NITYO INFOTECH
distrito federal, distrito federal
Publicado hace 7 días
Denunciar empleo