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Associate Director, Regulatory Ad/Promo

System One
Basking Ridge, NJ
  • Expired: September 02, 2022. Applications are no longer accepted.

Associate Director Regulatory Affairs - AdPromo Client in New Jersey - 100% remote

Full-time / Permanent

Educational requirement? Bachelor's degree in science or health related discipline (Advanced degree [PhD, MD, MS, PharmD] preferred)

OBJECTIVES/PURPOSE OF JOB The Associate Director, Advertising and Promotion, Prescription Drug Products, reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements.


+ Provides regulatory review of advertising and promotional materials, new campaigns and launch strategies for assigned products. Assures timely and accurate review of advertising and promotional material to meet internal timelines and requirements.

+ Implements regulatory strategies and solutions to assure all advertising and promotional materials are in compliance with regulatory requirements and company policies.

+ Monitors FDA activity including enforcement actions, guidance documents, etc. to analyze and assess impact on company products and communicates risk to PRC(s).

+ Trains regulatory staff as required.

+ Monitors competitor advertising to keep abreast of market promotional and advertising strategies and assesses potentially violative competitive materials for forwarding to the FDA Office of Prescription Drug Promotion (OPDP) or Advertising and Promotion Labeling Branch (APLB) as appropriate.

+ Continually assesses advertising and promotion - related processes and procedures to enhance efficiencies and compliance.

+ Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the impact of proposed labeling changes on product promotion.

+ Assures that promotional PIs and Important Safety Information are updated as appropriate.

+ Other job responsibilities as needed.


+ Bachelor's degree in science or health related discipline (Advanced degree [PhD, MD, MS, PharmD] preferred)

+ Detail-oriented with the ability to proofread and check documents for accuracy as well as consistency

+ Strong capability to work in a team environment

+ Strong business acumen and the ability to see business drivers outside of regulatory affairs

+ Working knowledge of the Rx product NDA and labeling processes

+ Previous course training in advertising and promotion and attendance at training conferences a plus

+ Excellent communication skills, both oral and written

+ Strong interpersonal skills with the ability to influence others, without authority, in a positive and effective manner


+ 5-7 years of relevant pharmaceutical industry experience with 3+ years of relevant prescription product advertising and promotion review experience preferred. Broad knowledge of the pharmaceutical industry Regulatory Affairs discipline for prescription drugs.

+ Demonstrated ability to contribute to a continuous learning and process improvement environment.

Therapeutic area is primary Dermatology & Gastro (G.I) for this role. They also focus on neurology and medical device.

System One, and its subsidiaries including Joule, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

System One


Basking Ridge, NJ
07920 USA



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