Promotional Regulatory Affairs Core Reviewer (Associate Director)

Delaware, DE Biotech/R&D/Science Job SummaryCore promotional regulatory reviewer for one or more key brand(s) or Primary promotional regulatory reviewer for non-key brand(s). Responsible for review and approval of promotional material and marketing activities for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast and electronic), sales training, sales training, faculty training, study recruitment advertisement and corporate affairs communication for the brand(s) supported. Lead or work on brand team or PRA Skill Center initiatives including supporting Primary Reviewers and Skills leaders on projects.Major Responsibilities · Responsible for review, approval, and promotional regulatory compliance of all proactively disseminated marketing material and information used for commercialization purposes. · Develop and implement US promotional regulatory strategies for the brand team supported. · Provide PRA support to the Emerging Brands including providing input into target product claims and profiles. · Responsible for the content of promotional regulatory submissions for the assigned non-key brands. o Take the lead to resolve promotional related issues for the brand team. o Primary contact and leads all meetings with DDMAC o Review and sign off of all labeling, promotional material, 2253 submissions and responses to DDMAC communication. · Identifies material needing medical/legal review and facilitates the review and approval of the material through serial or team review. · Primary reviewer for non-key brand (or supporting reviewer for one or more key brands) and responsible for coordinating review of promotional material for all segments (HCP, Consumer, Managed Markets) and media (Print, broadcast and electronic). Final decision maker for PRA at the Brand Team level for non-key brands. · Applies regulatory and therapeutic area clinical knowledge to brand team marketing objectives and initiatives and proposes creative solutions to challenging promotional campaigns that meet marketing objectives while minimizing regulatory risk. · Lead and facilitate cross -functional (legal, medical, PRA, MR and commercial), reconcile medical and legal comments, and facilitates resolution of disagreements. · As a primary reviewer, independently review and approve product promotional material including sales communication for non-key brands. Or As a supporting reviewer, review and approve product promotional material and sales communication under the strategic direction of the Primary Review Director for the Brand. · Liaison with the FDA/DDMAC under the direction of Primary Review Director or PRA Skills Leader · Support emerging brands under the direction of the PRA Skills Leader or Sr. Primary Review Director. · Implement Brand Strategy as per direction from the Primary Reviewer or the PRA skills leader across all segments · To drive the Brand promotional strategy, provide regulatory solutions at level 0-1.Internal Contacts/Customers · Brand Team Members · Regulatory Affairs Staff · Clinical Research Physicians · Brand Attorneys · Medical Resource Staff · Compliance · Corporate Affairs, HR, etc. · Sales and Marketing staff · Global Brand Teams (Emerging and DFL) · Health Economics and Outcomes Research · Study DeliveryExternal Contacts/Customers · Industry groups and professional associations · Vendors and consultants · FDA/DDMACNo direct reportsResponsibilitiesMinimum · Degree in pharmacy, pharmacology or other life sciences or equivalent experience · 5+ years experience in regulatory affairs with at least 2 years in review and approval of product promotional material or 10+ years relevant pharmaceutical experience · Working understanding of relevant promotional regulations and guidances including labeling, product promotion and scientific exchange of information · Comprehensive understanding of all AZ Business Policies pertaining to sales and marketing · Experience (1-3 years) interacting with DDMAC/FDA. · Demonstrated ability to review product promotional material, identify false and misleading information, and propose alternate solutions to mitigate risks · Ability to lead and facilitate team meetings and managing and resolving conflict · Experience working in a team-based environment · Excellent verbal, written and communication skills and ability to write and articulate scientific/regulatory arguments in a persuasive manner · Experience in project management · Demonstrated proficiency in the following competencies, ethics, standards, att. to detail, etc. Preferred · Direct experience interacting with FDA/DDMAC (1-2 years) · An understanding of drug development process · Pharmaceutical marketing or commercial experience We want you to build a balanced life at AstraZeneca. Your career is just one part of that. We offer competitive salaries, rewards and recognitions for your invaluable time and efforts. We also bring you all the things you need to for your life outside of your work: generous health and welfare benefits flexible scheduling child care programs learning and development opportunities fitness centers and other personal conveniences At AstraZeneca, we put people first. Whether it’s the patients we help or the employees who make everything we do possible. AstraZeneca is an equal opportunity employer. Visit AstraZeneca’s Online Recruitment Center to complete a profile and apply Click here to see all "AstraZeneca" opportunities EMAIL THIS JOB TO A FRIEND Learn more about AstraZeneca