Requisition #1788896  -  Promotional Regulatory Affairs Reviewer (Assoc Dir/Sr Mgr) - 2 Positions

Date Posted: 11-04-2009 Functional Area: Regulatory Affairs State: Delaware City: Delaware Other States: N/A Field/Home based position: No Search Band: Band 5 Department: Promotional Reg Affairs Responsibilities   Promotional regulatory reviewer for one or more AstraZeneca brands. Responsible for review and approval of promotional material and marketing activities for all segments (HCP, Consumer, Managed Markets), media (print, broadcast, electronic), sales training, faculty training, study recruitment advertisement and Corporate Affairs communications. Lead or work on PRA initiatives and Centers of Expertise. 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 assigned brand team(s) • Provide PRA support to the Emerging Brands, including providing input into target product claims and profiles • Responsible for the content of promotional regulatory submissions • Take the lead to resolve promotional-related issues for assigned brand team(s) • Identifies material needing medical and/or legal review; facilitates the review and approval of the material through serial, parallel, or team review • Apply regulatory, therapeutic area and clinical knowledge to brand team marketing objectives and initiatives; propose creative solutions to challenging promotional campaigns that meet marketing objectives while minimizing regulatory risk • Lead and facilitate cross-functional (Legal, Clinical, PRA, Medical Resources, Commercial) review team; facilitate resolution of disagreements • Liaison with the FDA/DDMAC under the direction of Primary Review Director or PRA Skills Leader. Qualifications   Minimum: • 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 • Experience interacting with FDA/DDMAC (1-3 years) • 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/resolving conflict • Experience working in a team-based environment • Excellent verbal, written and communication skills and ability to write and articulate persuasive scientific/regulatory arguments • Experience in project management • Demonstrated proficiency in the following competencies: ethics, standards, attention to detail Preferred: • Direct experience interacting with FDA (1-2 years; Review Division) • Understanding of drug development process • Pharmaceutical marketing or commercial experience

AstraZeneca is an Equal Employment Opportunity Employer No unsolicited search agency resume submissions accepted - no unsolicited phone calls from search agencies will be accepted.