Associate Director, Advertising and Promotion Regulatory Affairs
Gilead Sciences, Inc.Santa Monica, CA, United States30+ days ago
Job type
- Full-time
Job descriptionReview of promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies / best practices. Represent the commercial regulatory perspective at and chairing the promotional review committee (PRC) which includes cross functional partners from Marketing, Medical Affairs, and Business Conduct (US Legal). Serve as a liaison to the FDA’s Advertising and Promotional Labeling Branch for respective product(s) and will help ensure materials are submitted to FDA in a timely manner. Ability to understand and evaluate all perspectives and provide experienced professional commercial regulatory guidance. Characterization of the regulatory promotional perspective and reason at regulatory project team meetings, labeling meetings, brand team meetings and, as needed, providing training to cross-functional colleagues including members of the PRC. Responsible for reviewing and interpreting enforcement letters, keeping current with industry changes relating to advertising and promotion, interpreting new Guidances to Industry, and, as applicable, evaluating related internal policies / best practices and processes.Assume a leadership role in advising cross-functional stakeholders on the commercial regulatory impact of new campaign concepts and product labeling and may also be desired to provide strategic regulatory guidance on corporate communications and appropriate pre-approval communications with managerial oversight, as appropriate.Doctorate and 2+ years of relevant industry experience ORMaster’s and 8+ years of relevant industry experience ORBachelor’s and 10+ years of relevant industry experience ORAssociate and 12+ years of relevant industry experience ORHigh School Diploma / GED and 14+ years of relevant industry experience Regulatory review of promotional materials for prescription drug and / or biologic products Oncology, immunology, and / or other relevant therapeutic area experience is desirable. An advanced degree is also desirable. Experience working with FDA’s Office of Prescription Drug Promotion or Advertising and Promotional Labeling Branch is preferred. Excellent verbal and written communication skills and interpersonal skills are desired. Must be capable of developing and implementing commercial regulatory strategy and managing complex negotiations with internal and external stakeholders. Assumes a leadership role in updating and advising Company stakeholders on changes in regulations, policies, and enforcement which may impact the Company’s promotional activities. The position will be recognized as a knowledgeable resource for commercial regulatory advice on promotional, corporate and other non-promotional initiatives in other departments.Everyone at Kite is grounded by one common goal – curing cancer. Every day, we aim to establish a direct line between that purpose and our day-to-day work.
#J-18808-Ljbffr
Create a job alert for this search
Regulatory Promotion • Santa Monica, CA, United States
Related jobs
Woodland Hills law firm seeks Associate Attorney with experience in Civil Litigation.Experience in Trust and Probate Litigation, Probate and Trust Administration is a plus.Friendly, small firm envi...Show moreLast updated: 1 day ago
Quality Assurance Director Needed - $165K-$190K - Growing Manufacturing Firm!.This Jobot Job is hosted by : Steven Zacharias.
Are you a fit? Easy Apply now by clicking the "Apply Now" button and send...Show moreLast updated: 4 days ago
Iconic British brand ghd, is a global leader in high end professional hair styling tools and the UK’s number one recommended styling brand.
Loved by stylists and consumers, loved by press, and...Show moreLast updated: 2 days ago
Learn more about the general tasks related to this opportunity below, as well as required skills.Review of promotional, corporate, and other non-promotional materials to assess for compliance with ...Show moreLast updated: 30+ days ago Review of promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies / best practices.Represent th...Show moreLast updated: 30+ days ago 
Our Associate Account Director leads our account / project teams and initiatives with a refined combination of strategy, curiosity and passion.
You will be helping to ensure the success of high-profil...Show moreLast updated: 4 days ago
Boldly built for every fandom, Tubi is a free streaming service that entertains over 100 million monthly active users.Tubi offers the world's largest collection of Hollywood movies and TV shows, th...Show moreLast updated: 4 days ago
You'll partner with the Creative Director to lead concept development, campaign thinking, and execution across a team of talented designers, writers, and content creators.This isn't about checking ...Show moreLast updated: 4 days ago
Sinclair’s content technology is at the core of our operational excellence.We thrive on innovation and a passion for connecting people with the best local news and sports content.As we grow our con...Show moreLast updated: 30+ days ago
Join Opinion Edge today and get paid for your insights! Take short surveys on the topics that matter to you and earn rewards for every completed survey.
Sign up now and start turning your voice into...Show moreLast updated: 2 days ago
You'll partner with the Creative Director to lead concept development, campaign thinking, and execution across a team of talented designers, writers, and content creators.This isn't about checking ...Show moreLast updated: 4 days ago Bachelor’s Degree and 8+ years of experience, • OR Master’s Degree and 6+ years of experience, • OR Advanced scientific degree (MD, PharmD, PhD) and 4+ years of experience • Experience in pharmaceutic...Show moreLast updated: 5 days ago Associate Director of Product, Gameplay - removed.As Associate Director of Product for Gameplay, you are responsible for driving the success of gameplay initiatives on Call of Duty : Mobile.You will...Show moreLast updated: 30+ days ago 
We’re looking for an experienced and deeply passionate marketing leader to join a new publishing leadership team for one of Riot’s upcoming R&D titles.
GTM, and directing marketing for a live-servic...Show moreLast updated: 30+ days ago Review of promotional, corporate, and other non-promotional materials to assess for compliance with the applicable regulations, guidance documents, and internal policies / best practices.Represent th...Show moreLast updated: 30+ days ago 
We are looking for a data-savvy.In this contract-based role, you’ll play a key part in a high-impact initiative, reporting directly to the Head of Integrated Systems in our Digital & Tech...Show moreLast updated: 30+ days ago
Anticipated hiring range is near or at the minimum of the classification,.Open Until Filled, Apply Immediately.Reporting to the Executive Director of Development & Alumni Engagement, Woodbury Campu...Show moreLast updated: 4 days ago
Director of Development, College of Arts, Media & Communication.MPP, Administrative, At-Will, Full Time, On-site (work in-person at business location).
At CSUN we aspire to continually grow as an in...Show moreLast updated: 30+ days ago
- Promoted
Associate Attorney
US MainWOODLAND HILLS, CA, USFull-time
- Promoted
Quality Assurance Director
JobotSanta Clarita, CA, USFull-time
- Promoted
Sr. Director of Ecommerce
ghdCalabasas, CA, USFull-time
Associate Director, Advertising and Promotion Regulatory Affairs
MediabistroSanta Monica, CA, United StatesFull-time
Associate Director, Advertising and Promotion Regulatory Affairs Job at Gilead S
MediabistroSanta Monica, CA, United StatesFull-time
- Promoted
Associate Account Director
Tilt.comLos Angeles, CA, United StatesFull-time
- Promoted
Associate Creative Director
TubiLos Angeles, CA, United StatesFull-time
- Promoted
Associate Creative Director
HeimatWest Hollywood, CA, United StatesFull-time
- Promoted
Director, Content Rights Management
Sinclair Broadcast GroupLos Angeles, CA, USFull-time
- Promoted
Share Your Opinions. Earn Rewards.
Opinion EdgeAltadena, CA, United StatesFull-time
- Promoted
Associate Creative Director
John Reed FitnessWest Hollywood, CA, United StatesFull-time
- Promoted
Associate Director, US Market Access Strategy & Effectiveness
Gilead Sciences, Inc.Santa Monica, CA, United StatesFull-time
Associate Director of Product, Gameplay Santa Monica (USA) Activision Publishing
MediabistroSanta Monica, CA, United StatesFull-time +1
- Promoted
Director, Brand Management - Unpublished R&D Product
Riot GamesLos Angeles, CA, United StatesFull-time
Gilead Sciences, Inc. is hiring : Associate Director, Advertising and Promotion R
MediabistroSanta Monica, CA, United StatesFull-time
- Promoted
Data Coordinator
LHHAltadena, CA, USTemporary
- Promoted
Associate Director of Development & Alumni Engagement
University of RedlandsBurbank, CA, United StatesFull-time
- Promoted
Director of Development, College of Arts, Media & Communication
California State UniversityNorthridge, CA, United StatesFull-time +1