Regulatory Labeling, Advertising and Promotion Manager
2 weeks ago
Make 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 with different functions of the business.
About the Job:
Act as regulatory approver of all advertising and promotional materials for assigned product, and take an active role in supporting the submission of these materials to the FDA. As the regulatory representative in the cross functional team creating the advertising and promotional materials, bring product knowledge, information on previous submissions, FDA enforcement trends, and the competitive landscape to all discussions. Ability to effectively explain, describe or convey information to a variety of audiences. Specifically, communicates effectively strategies to Supply Chain.
Supports the Labeling Scientist Lead in development of new labeling content in collaboration with cross functional project team. Manages the creation and maintenance of all US product labeling components using the established labeling and artwork procedures in collaboration with the Regulatory Labeling, Advertising and Promotion Scientists. Compilation of labeling documents for all submissions which include labeling information. Responsible for drug listing for product manufactured by UCB for distribution within the US.
Promotional Material/External Communications Responsibilities:
- Develop and maintain current knowledge of requirements for US regulation of drug marketing and advertising and competitive landscape. Communicate FDA requirements to other UCB departments involved in the preparation or review of external communication materials.
- Supports complex OPDP submissions in collaboration with UCB 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.
Labeling Responsibilities:
- 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.
- Manage LRC and GLF reviews and approvals and artwork revisions to US labeling components using the established processes.
- Manage generation of SPL for inclusion in labeling submissions and drug product listings.
Who you'll work with:
- Collaborate with Supply Chain to coordinate implementation strategy for new labeling artwork
- Interface with the Global Labeling Function (GLF) to ensure consistency of labeling processes and local compliance with CCDS.
- Collaborates with co-creation partners in the development of new promotional initiatives/programs and reviews supporting materials ensuring compliance and consistency with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act. Negotiates promotional regulatory position within cross-functional team
Interested? For this role we're looking for the following required education, experience and skills:
- 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.
Salary Range: $121,920 to $160,020
Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.
As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US- for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Requisition ID: 85326
Recruiter: John Gasbarre
Hiring Manager: Oana E Pop
Talent Partner: Bianca Hinshaw
Job Level: SA I - MM II
Please consult HRAnswers for more information on job levels.
-
Atlanta, Georgia, United States UCB Full timeMake 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 communication skills to join our Regulatory Labeling, Advertising and Promotion team...
-
Labeling Advertising and Promotion Manager US
16 hours ago
Atlanta, Georgia, United States UCB Full timeMake 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 communication skills to join our Regulatory Labeling, Advertising and Promotion team...
-
Head Global Labelling, Promotion
6 days ago
Atlanta, Georgia, United States UCB Full timeMake your mark for patientsWe are looking for a Head of Global Labelling, Promotion & Advertisement to join us in our Global Regulatory Affairs team, based in either our Brussels, Belgium or Atlanta, Georgia (U.S.) offices. About the roleThe Head of Global Labelling & Promotion is a member of the Global Regulatory Affairs Leadership Team (GRA-LT) and...
-
US Labeling
6 days ago
Atlanta, Georgia, United States UCB Full timeMake your mark for patients About the role: Regulatory Labeling, Advertising and Promotion Lead (Associate Director) 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 communication skills to join our Regulatory Labeling, Advertising...
-
Associate Manager, Advertising
1 month ago
Atlanta, Georgia, United States Arbys Full timeThe Associate Manager, Advertising is responsible for supporting the day-to-day advertising initiatives for Arby's. This position will play a key role in the development and execution of advertising campaigns as part of the Annual Marketing Calendar. This individual will support the strategy of the calendar and campaigns, in partnership with the integrated...
-
Regulatory Scientist
1 month ago
Atlanta, Georgia, United States UCB Full timeMake your mark for patientsWe are looking for a Regulatory Scientist who is motivated, ambitious and eager to learn to join us in our Global Regulatory Affairs team, based in our Atlanta, GA or our Raleigh, NC offices. About the role:You will be responsible for preparing and delivering regulatory operational plans for allocated projects/products; project...
-
Promotions Coordinator
6 days ago
Atlanta, Georgia, United States PrizePicks Full timeAt PrizePicks, we are the fastest growing sports company in North America, as recognized by Inc As the leading platform for Daily Fantasy Sports, we cover a diverse range of sports leagues, including the NFL, NBA, and Esports titles like League of Legends and Counter-Strike. Our team of over 450 employees thrives in an inclusive culture that values...
-
Biological Science Technician
1 month ago
Atlanta, Georgia, United States Department Of Health And Human Services Full timeSummary This position is located in the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Regulatory Science (ORS), which performs a full range of microbiology technician work in support of the assigned laboratory. DutiesStudies the sample labeling, collection report, and other pertinent information to understand the problem...
-
Atlanta, Georgia, United States Delta Airlines Full timeCo-op, Flight Operations – Regulatory Compliance (Fall, 2024) United States, Georgia, AtlantaFlight Ops30-Jan-2024Ref #: 23196LinkedIn Tag: #LI-MP2How you'll help us Keep Climbing (overview & key responsibilities)Delta Air Lines, Inc.Delta Air Lines is one of the world's leading international airlines, and our number one focus is to enhance all aspects of...
-
Quality Assurance Manager
4 hours ago
Atlanta, Georgia, United States The Judge Group Inc. Full timeLocation: REMOTESalary: $130,000.00 USD Annually - $150,000.00 USD AnnuallyDescription: Our client is currently seeking a Quality Assurance Manager Quality Assurance Manager will be a pivotal role in ensuring the highest standards of quality and compliance throughout the product development lifecycle. This position involves overseeing and implementing...
-
Quality Manager
2 weeks ago
Atlanta, Georgia, United States Ag Jobs Full timeThe Manager is responsible for overseeing and implementing the Unit's Quality, Health, Safety, and Environment policies, procedures, and initiatives. The individual may lead a team of QHSE professionals and collaborate with cross-functional departments to ensure compliance with relevant regulations, promote a culture of safety, improve operational...
-
Regulatory Reporting Analyst
6 days ago
Atlanta, Georgia, United States Truist Full timeThe position is described below. If you want to apply, click the Apply Now button at the top or bottom of this page. After you click Apply Now and complete your application, you'll be invited to create a profile, which will let you see your application status and any communications. If you already have a profile with us, you can log in to check status.Need...
-
Administrative Assistant
3 weeks ago
Atlanta, Georgia, United States Nuclear Regulatory Commission Full timeThe successful candidate will serve as the principal administrative assistant to one or more branch chiefs of the Division of Reactor Projects, performing the full range of administrative duties.Such duties include but are not limited to:Prepares letters, memoranda and reports in final form from drafts, entering them into ADAMS.Reviews and proofreads...
-
Network Development Engineer
2 weeks ago
Atlanta, Georgia, United States PacketFabric Full timePacketFabricNetwork Development Engineer - Architecture GroupTHE 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 PacketFabric network utilizes a wide array of networking equipment from multiple vendors, so you must come armed with...
-
Technical Program Manager
6 days ago
Atlanta, Georgia, United States SiriusXM - Pandora Full timeTechnical Program ManagerWho We Are:SiriusXM and its brands (Pandora, SXM Media, AdsWizz, Simplecast, and SiriusXM Connected Vehicle Services) are leading a new era of audio entertainment and services by delivering the most compelling subscription and ad-supported audio entertainment experience for listeners -- in the car, at home, and anywhere on the go...
-
Manager, Resource Management
3 weeks ago
Atlanta, Georgia, United States Southern Company Full timeRESOURCE MANAGEMENT MANAGERThe purpose of this position is to oversee and manage the work distributed to field resources that supports the Southern Company Gas mission of safe and reliable operation of the gas distribution system. This role works collaboratively with Field Operations Regional Directors and other Business Functional Unit leaders to execute on...
-
Roadway Project Manager
6 days ago
Atlanta, Georgia, United States AtkinsRéalis Full timeJob Description Why join us? It's an exciting time at AtkinsRéalis We are rapidly growing in the US. Our company purpose is to build a better world for our planet and its people. We recognize the importance of making sure that our clients and employees, feel this purpose every day. AtkinsRéalis is proud of our company culture that promotes, diversity,...
-
Manager Fleet Safety and Training
6 days ago
Atlanta, Georgia, United States CRH Full timeJob ID: 493844 Oldcastle APG, a CRH Company, is the leading provider of outdoor living solutions in North America with an award-winning portfolio that enables customers to Live Well Outside. Inspiring endless possibilities with enduring performance, its collection of premier building products create inviting outdoor spaces where people connect, reflect and...
-
Compliance Manager
6 days ago
Atlanta, Georgia, United States teamworkonline Full timeAt PrizePicks, we are the fastest growing sports company in North America, as recognized by Inc As the leading platform for Daily Fantasy Sports, we cover a diverse range of sports leagues, including the NFL, NBA, and Esports titles like League of Legends and Counter-Strike. Our team of over 450 employees thrives in an inclusive culture that values...
-
Program Operations Manager
6 days ago
Atlanta, Georgia, United States SiriusXM Radio, Inc. Full timeWho We Are:SiriusXM and its brands (Pandora, SiriusXM Media, AdsWizz, Simplecast, and SiriusXM Connect) are leading a new era of audio entertainment and services by delivering the most compelling subscription and ad-supported audio entertainment experience for listeners -- in the car, at home, and anywhere on the go with connected devices. Our vision is to...