Senior Manager

Allergan is a $23 billion diversified global pharmaceutical company and a leader in a new industry model - Growth Pharma.

Allergan is hiring for a Sr. Manager, Advertising and Promotion Compliance position, to be located in Irvine, CA.

- The Sr. Manager, Advertising and Promotion Compliance, is responsible for providing operational leadership and sound regulatory advice consistent with applicable FDA regulations and guidance documents, FTC regulations, PhRMA guidelines, and company policy while meeting business needs for assigned products at every stage of the development of promotional programs/materials. - This individual supports the team in providing sound regulatory rationale as well as interactions with other members of the Review Committee (RC) team. Trains Analysts, Specialists and Managers. - This incumbent will work collaboratively with the business to ensure that promotional practices are consistent with regulatory guidelines and support business objectives. - Proposes creative solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk. S/he supports US brand teams, Public Affairs Department and others by participating in strategy discussions and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics. - S/he will provide regulatory input on concepts and draft promotional materials to help assure promotional materials satisfy U.S. promotional regulations, corporate standards and policies and business objectives. - The Senior Manager, Advertising and Promotion Compliance, will identify continuous improvement opportunities, initiates improvements in department processes, develops staff to assume greater or more diverse responsibilities. - S/he trains new hires and other Specialists and Associates. - This incumbent identifies and provides suggestions and manages the process for improvements/corrections within the Advertising and Promotion Compliance department. - S/he will maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical/biologics industry. - S/he will communicate significant changes in FDA perspective to relevant stakeholders. - The Senior Manager, Advertising and Promotion Compliance, maintains a productive relationship with FDA to help ensure successful and timely review of advisory submissions and effective resolution of regulatory actions. - S/he under limited guidance of the Director/Sr. Director develops and implements effective strategies for FDA submissions for advisory. - Manage the development of correspondence with FDA and the interpretation of FDA advisory comments for assigned products.

- A minimum of a BS Degree in a biological or healthcare scientific discipline or equivalent with 10 years relevant industry experience required. An advanced degree, i.e., MS, PhD, MBA, JD, and PhD in a biological or healthcare scientific discipline or equivalent with 6 years relevant industry experience preferred. - The successful candidate is required to have demonstrated experience in pharmaceutical/biologics regulatory or scientific disciplines with a demonstrated history of successful interactions with OPDP. - A minimum of 3 years in the review of prescription drug advertising and promotion for compliance with applicable FDA laws, regulations and guidance documents or equivalent industry discipline required. - The successful candidate is required to have sound basis of regulatory knowledge specific to advertising and promotion of drugs, devices and cosmetics. - The ability to demonstrate strategic and analytical thinking is required as is demonstrated ability to facilitate appropriate team discussions and decisions. - Strong organizational skills and attention to details preferred. - The successful candidate is required to have excellent computer skills. - Excellent verbal and written communication skills, analytical skills and interpersonal skills required. The successful candidate is required to have an in depth knowledge of the regulation and regulatory processes pertaining to advertising and promotion of prescription and OTC drugs, and cosmetics acquired through experience. - Ability to manage complex projects and timelines in a matrix team environment with the ability to lead and coach others preferred. - This position is located in Irvine, California and may require minimal travel <20%.