Director of Regulatory Affairs

Job Description The Associate Director/Manager/Sr Manager/Director, Advertising and Promotion will provide strategic support to the review of Advertising and Promotion materials in order to meet the US brand team’s objectives while ensuring the necessary level of regulatory compliance. This includes: Ensure business compliance and implementation of and adherence to Regulatory standards. Regulatory review of any internal and external business communications. Engage in appropriate activities in order to improve the regulatory environment through Agency contacts: Office of Prescription Drug Promotion (OPDP) and trade associations as appropriate. Mentoring newer staff members across the varied disciplines across multiple review committees. Enhancing collaboration across a matrixed organization while developing and maintaining constructive relationships. Job Responsibilities Provide strategic Regulatory support to the review of Advertising and Promotion materials in order to meet the US brand team’s objectives while ensuring the necessary level of regulatory compliance. This includes: Ensures business compliance and implementation of and adherence to Regulatory standards. Regulatory review of any internal and external business communications. This includes NY support for Sales and Marketing initiatives and programs. Engages in appropriate activities in order to improve the regulatory environment through Agency contacts: Office of Prescription Drug Promotion (OPDP) and trade associations as appropriate. Mentors newer staff members across the varied disciplines across multiple review committees. Enhances 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, applies 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. Technical Skills Required 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 environment. 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. Exceptional communication, negotiation and partnering skills are a must. 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. 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. #RegulatoryAffairs #AdPromo #PharmaceuticalRegulatory #AdvertisingAndPromotion #OPDP #FDARegulatory #LifeSciences #Pharmaceutical #Biotech #RegulatoryCompliance #DrugPromotion #RegulatoryStrategy #LI-AF1 #J-18808-Ljbffr