- At least 3 years of relevant experience in the pharmaceutical industry, with preferably 2 years in Regulatory Affairs and specific experience in US advertising and promotion material review and approval, and labeling. Basic knowledge of US labeling and promotion regulations and guidance.
- Knowledge of science and data of assigned products and how that translates into labeling language.
- Knowledge of competitive landscape and how other companies are dealing with similar issues in labeling and promotion.
- Supports complex OPDP submissions in collaboration with company contract support.
- Participates in and/or directs the regulatory review of non-promotional scientific information, and external communication materials, including media information and provides proactive feedback.
- Develop and maintain current knowledge of US regulation of labeling and industry standards for labeling and communicate requirements to other departments in a timely manner.
- Direct the labeling control process for tracking, implementation and regulatory submission of changes to existing labeling.
- Compilation of Labeling Review Committee (LRC) packages for all US labeling components.
-
Manager, US Labeling and Advertising
4 weeks ago
Proclinical Staffing Atlanta, United StatesManager, Regulatory Affairs, Advertising, Promotion & Labeling - Permanent - Remote · Proclinical is seeking a remote Manager, Regulatory Affairs - Advertising, Promotion & Labeling for a global biopharmaceutical company located in Georgia. · Primary Responsibilities: · In this r ...
-
UCB S.A. Atlanta, United StatesMake your mark for patients · Regulatory Labeling, Advertising and Promotion Manager · We're looking for a Regulatory Labeling, Advertising and Promotion Manager that is open minded, focused, and willing to step up and focus on bringing solutions to the table and partner well wi ...
-
UCB Atlanta, United StatesMake your mark for patients · Regulatory Labeling, Advertising and Promotion Manager · We're looking for a Regulatory Labeling, Advertising and Promotion Manager that is open minded, focused, and willing to step up andfocus on bringing solutions to the table and partner well w ...
-
UCB Atlanta, United States OTHERMake your mark for patients · About the role: · Regulatory Labeling, Advertising and Promotion Manager · We're looking for a Regulatory Labeling, Advertising and Promotion Lead that works with integrity, has strategic orientation, is flexible/adaptable to change and has excellent ...
-
UCB Atlanta, United States OTHERMake your mark for patients · Regulatory Labeling, Advertising and Promotion Manager · We're looking for a Regulatory Labeling, Advertising and Promotion Manager that is open minded, focused, and willing to step up and focus on bringing solutions to the table and partner well wit ...
-
Advertising Sales Professional
2 weeks ago
TheHomeMag | America's #1 Home Improvement Magazine ® Atlanta, United StatesTheHomeMag is America's #1 Home Improvement Magazine and we are celebrating over 20 fabulous years of continuous growth – and our progress into 2024 is no different. · We are looking for a full-time Account Executive for our corporately-owned and operated Atlanta publication. Nat ...
-
Culinary Supervisor
2 weeks ago
Compass Group USA Atlanta, United StatesCulinary Supervisor - State Farm ArenaClick Here to Apply OnlineJob Description Levy Sector Position Title: Concessions Supervisor - State Farm ArenaStarting Pay: $19 per hourWe Make Applying Easy Want to apply to this job via text messaging? Text JOB to 75000 and search requisit ...
-
Pastry Supervisor-Mercedes Benz Stadium
2 weeks ago
Compass Group USA Atlanta, United StatesPastry Supervisor-Mercedes Benz StadiumClick Here to Apply OnlineJob Description Levy Sector Position Title: [[title]]Pay Range: $20.00 to $20.00 We Make Applying Easy Want to apply to this job via text messaging? Text JOB to 75000 and search requisition ID number The advertised ...
-
Warehouse Associate
2 weeks ago
Republic National Distributing Company Atlanta, United StatesWarehouse Associate - Night · Location: Atlanta, GA, US, 30336 · Req ID: Work Location Type: On Site Date: Apr 24, Republic National Distributing Company (RNDC) is a family-owned business with roots extending before Prohibition that has evolved into one of the nation's l ...
-
Associate Director
3 weeks ago
Piper Companies Atlanta, United StatesPiper Companies is searching for an Experienced Regulatory Affairs Professional in Advertising & Promotion to lead the neurology regulatory affairs team of a global biopharmaceutical company as Associate Director of Regulatory Affairs (Advertising & Promotion). The position is a ...
-
Associate Director
2 days ago
Piper Companies Atlanta, United StatesPiper Companies is searching for an Experienced Regulatory Affairs Professional in Advertising & Promotion to lead the neurology regulatory affairs team of a global biopharmaceutical company as Associate Director of Regulatory Affairs (Advertising & Promotion). The position is a ...
-
Network Development Engineer
4 weeks ago
PacketFabric Atlanta, United StatesJob Description · Job DescriptionPacketFabric · Network Development Engineer - Architecture Group · THE ROLE:As a well rounded Network Development Engineer, you should be the type that appreciates diversity in your day, and relishes challenges outside of your comfort level The Pa ...
-
pizza cook
2 days ago
Compass Group, North America Atlanta, United States Full timeBon Appetit · + We are hiring immediately for full time PIZZA COOK positions. · + Location: SCAD Atlanta Peachtree St. NE Atlanta, GA Note: online applications accepted only. · + Schedule: Full time schedule. 2:00 pm to 10:00 pm. Days may vary, weekends included. More details ...
-
prep cook
2 days ago
Compass Group, North America Atlanta, United States Part timeBon Appetit · + We are hiring immediately for a part time PREP COOK position. · + Location: SCAD Atlanta Spring Street, Atlanta, GA Note: online applications accepted only. · + Schedule: Part time schedule. Evening shifts and weekends. Hours and days may vary; more details upo ...
-
prep cook
2 days ago
Compass Group USA Atlanta, United States Full timePREP COOK (FULL TIME)Click Here to Apply OnlineJob Description Flik Hospitality Group We are hiring immediately for full time PREP COOK positions.Location: Westminster School West Paces Ferry Road, Northwest, Atlanta GA 30327 Note: online applications accepted only.Schedule: Full ...
-
PREP COOK
2 days ago
Compass Group USA Atlanta, United StatesPREP COOK (FULL TIME and PART TIME)Click Here to Apply OnlineJob Description Bon Appetit We are hiring immediately for a full time and part time PREP COOK position.Location: SCAD ATLANTA Peachtree Street Northwest, Atlanta, GA 30309 Note: online applications accepted only.Schedul ...
-
Warehouse Associate
2 weeks ago
Republic National Distributing Company Atlanta, United StatesRepublic National Distributing Company (RNDC) is a family-owned business with roots extending before Prohibition that has evolved into one of the nation's largest wine and spirits wholesalers. Our success is grounded in our core values of Family, Service, Accountability, Honesty, ...
-
senior cook
2 days ago
Compass Group USA Atlanta, United States Full timeSENIOR COOK (FULL TIME)Click Here to Apply OnlineJob Description Flik Hospitality Group We are hiring immediately for full time SENIOR COOK position.Location: Norfolk Southern - 650 West Peachtree Street, Atlanta GA 30308 Note: online applications accepted only.Schedule: Full tim ...
-
hourly cook supervisor
2 days ago
Compass Group USA Atlanta, United States Full timeHOURLY COOK SUPERVISOR (FULL TIME)Click Here to Apply OnlineJob Description Bon Appetit We are hiring immediately for a full time HOURLY COOK SUPERVISOR position.Location: SCAD ATLANTA Spring Street, Atlanta, GA 30309 Note: online applications accepted only.Schedule: Full time sc ...
-
Senior Software Engineer
2 days ago
ESHA Research Atlanta, United StatesTrustwell is revolutionizing the Food Industry with Cutting-Edge Solutions · Are you ready to make a real impact on the way we eat? Join Trustwell, the industry leader in providing nutritional information, food safety, and innovative software as a service ("SaaS") compliance sol ...
Manager, US Labeling and Advertising - Atlanta, United States - Proclinical Staffing
Description
Manager, Regulatory Affairs, Advertising, Promotion & Labeling - Permanent - Remote
Proclinical is seeking a remote Manager, Regulatory Affairs - Advertising, Promotion & Labeling for a global biopharmaceutical company located in North Carolina.
Primary Responsibilities:
In this role, you will serve as a regulatory approver of all advertising and promotional materials for assigned product(s) and take an active role in supporting the submission of these materials to the FDA. You will develop and maintain current knowledge of requirements for US regulation of drug marketing and advertising and competitive landscape. In addition, you will collaborate with co-creation partners in the development of new promotional initiatives/programs and reviews supporting materials ensuring compliance with regulations.
The position can be based at their Georgia site (preferred) or remote-based within the United States.
Skills & Requirements:
The Manager, Regulatory Affairs, Advertising, Promotion & Labeling will:
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at or .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Manager, US Labeling and Advertising professionals in Atlanta
-
Nikhil Mayakuntla
Java Developer
-
ANGELO MOLINO
Composer, Pianist , Wellness and Health expert