Associate Director, Regulatory Affairs Advertising & Promotion

Summit, NJ, US
Nov 21, 2018
Required Education
Bachelors Degree
Position Type
Full time
Req #: 1802662
Location: Summit, New Jersey, United States
Job Category: Regulatory Affairs
Work Location: 86 Morris Avenue 07901
Organization: Regulatory Affairs
Employee Status: Full-time
Job Type: Regular


Responsibilities will include, but are not limited to, the following:
  • Provide strategic regulatory guidance on advertising and promotion materials and activities, including the development of launch materials/new claims, in accordance with business goals and objectives.
  • Review and approve of advertising and promotional materials for marketed products, press, educational, and training materials as assigned.
  • Review and approve of direct-to-consumer (DTC) pharmaceutical broadcast advertising and print materials.
  • Ensure regulatory compliance with all applicable laws, regulations and regulatory guidelines governing promotional programs and scientific interactions with healthcare professionals, payers, advocacy, and other business partners.
  • Provide risk assessment for marketing and medical campaigns.
  • Propose regulatory advisory submission strategies, prepare communications, and oversee the timely and accurate submission of promotional materials to OPDP.
  • Maintain up-to-date knowledge of US regulatory promotional environment by reviewing regulatory promotional guidelines and enforcement letters to pharmaceutical companies, advising internal stakeholders as warranted.
  • Provide training in FDA regulations for advertising and promotion to internal employees.
  • Ensures that changes in US Package Insert are appropriately implemented and reflected in current promotions and advertising.
  • Coach and mentor junior staff within the department.
  • Foster and facilitate teamwork within the Promotional Approval Cross-functional Team (PACT) process.

Key Requirements/Knowledge:
  • Bachelor's degree in science (BS) required. Advanced degree (MS, MPH, PharmD, PhD, or JD) preferred.
  • 5-9 years pharmaceutical industry experience with 3-5 years in regulatory affairs, with at least 3 years in regulatory advertising and promotion.
  • Knowledge of FDA advertising and promotion regulations and guidance is necessary.
  • Experience with regulatory review and approval of direct-to-consumer pharmaceutical advertising (Broadcast DTC experience is a plus)
  • Understanding of, and experience with, regulatory framework applicable to interactions with healthcare providers, payers, advocacy, and other business partners.
  • Proven ability to analyze and interpret efficacy and safety data.
  • Excellent communication, listening, and negotiation skills, the ability to strategically influence business partners and FDA, and a mature appreciation of how the commercial objectives of the company can be delivered, while at the same time meeting FDA compliance standards, are necessary
  • Leadership skills and demonstrated ability to influence teams is required.
  • Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously.
  • Must be innovator of new ideas and best practices.
  • Must recognize potential problems and resolve problems.
  • Possess outstanding attention to detail.
  • Domestic travel may be necessary.

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

About Us


At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.

"At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients."

There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.