US Labeling

3 weeks ago

Atlanta, Georgia, United States UCB Full time

Make 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 and Promotion team in Atlanta, GA.

Primary Purpose / Regulatory Responsibilities:

This individual will provide oversight of the US Regulatory Labeling, Advertising and Promotion team and manage a team of direct reports. In collaboration with Regulatory Labeling, will serve as an Advertising and Promotion Expert representative on project teams and committees where decisions and outcomes potentially impact all products.

What you'll do:

Labeling Responsibilities

  • US Regulatory expert in US regulation of advertising and promotion and industry standards for labeling and communicate requirements to others as needed.
  • Oversight of the development and maintenance of procedures for the regulatory aspects of labeling preparation, review, approval and submission.
  • Direct the labeling control process for tracking, implementation and regulatory submission of changes to existing labeling.
  • Interface with the Head of Global Labeling Function to ensure consistency of labeling processes and local compliance with CCDS.
  • Serve as US Regulatory labeling expert in internal and external audits.
  • Oversight of CAPA resolution.
  • Serve as US Regulatory labeling expert in project teams for activities impacting labeling across multiple products.
  • Provide oversight of FDA establishment registration, drug product listing, and import procedures in collaboration with Regulatory Labeling and Advertising and Promotion Manager, US.
  • Provide back up support to Regulatory Labeling, Advertising and Promotion Scientists and Managers as needed based on workload.

Promotional Material/External Communications Responsibilities

  • US Regulatory expert regarding requirements for US regulation of drug marketing and advertising and competitive landscape. Communicate FDA requirements and trends to other UCB departments involved in the preparation or review of external communication materials.
  • Provides guidance to Regulatory Labeling, Advertising and Promotion Scientists as needed during negotiations in cross functional teams.
  • Serve as US Regulatory lead in cross functional teams where promotional or scientific communication policies/procedures are being developed or revised.
  • Serve as back up to Regulatory Labeling, Advertising and Promotion Scientists, US as needed in cross functional promotion committee meetings.

Management responsibilities:

  • Provide leadership and guidance to Regulatory Labeling, Advertising and Promotion Scientists and Managers, US.
  • Interact with senior management, external departments and regulatory authorities as needed.
  • Participate in forecasting and planning activities for US Regulatory Labeling resources.

Interested? For this position, you'll need the followingeducation, experience,andskills :

Minimum Qualifications:

Bachelors Degree with 7+ years of relevant experience in the pharmaceutical industry with 5+ years in Regulatory Affairs and specific experience in US Advertising and Promotion/Labeling experience.

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.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

Requisition ID: 86051

Recruiter: John Gasbarre

Hiring Manager: Leo Anthony DiNapoli

Talent Partner: Bianca Hinshaw

  • US Labeling Scientist

    14 hours ago

    Atlanta, Georgia, United States UCB Full time

    Make your mark for patients UCB is looking for an exceptional US Labeling Scientist who will lead development of new labeling content in collaboration with a cross functional project team. They will manage the creation and maintenance of all US product labeling components using the established labeling and artwork procedures in collaboration with the...

  • Labeling Advertising and Promotion Manager US

    4 weeks ago

    Atlanta, Georgia, United States UCB Full time

    Make 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

    1 month ago

    Atlanta, Georgia, United States UCB Full time

    Make 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

    3 weeks ago

    Atlanta, Georgia, United States UCB Full time

    Make 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

    1 month ago

    Atlanta, Georgia, United States UCB Full time

    Make 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...

  • Regulatory Labeling, Advertising and Promotion Manager

    3 weeks ago

    Atlanta, Georgia, United States UCB Full time

    Make your mark for patients Regulatory Labeling, Advertising and Promotion ManagerWe'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...

  • Regulatory Labeling, Advertising and Promotion Manager

    1 week ago

    Atlanta, Georgia, United States UCB S.A. Full time

    Make your mark for patients Regulatory Labeling, Advertising and Promotion ManagerWe'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...

  • Regulatory Labeling, Advertising and Promotion Manager

    1 month ago

    Atlanta, Georgia, United States UCB Full time

    Make your mark for patients Regulatory Labeling, Advertising and Promotion ManagerWe'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...

  • Groundskeeper - Porter

    7 days ago

    Atlanta, Georgia, United States Premier Living US Full time

    We're hiring a Groundskeeper - Porter to provide high-quality landscaping services to our customers. Under the supervision of the crew leader, you'll be responsible for mowing, mulching, edging, fertilizing, raking, pruning, and other lawn care and maintenance duties. If you love working with your hands and delivering quality workmanship, send us your...

  • Groundskeeper - Porter

    1 week ago

    Atlanta, Georgia, United States Premier Living US Full time

    Job DescriptionJob DescriptionWe're hiring a Groundskeeper - Porter to provide high-quality landscaping services to our customers. Under the supervision of the crew leader, you'll be responsible for mowing, mulching, edging, fertilizing, raking, pruning, and other lawn care and maintenance duties. If you love working with your hands and delivering quality...

  • Senior Project

    7 days ago

    Atlanta, Georgia, United States Bankgreenwood Full time

    ****Join Us**** Our commitment to culture and community is evident as we recruit top talent in the areas of Engineering, Product, Banking and Finance, Marketing, Operations, Customer Service, and Administration. We know that our success is your success and we are building an employee-focused culture where we work together in a collaborative and rich...

  • Clinical Supply Chain Manager

    1 week ago

    Atlanta, Georgia, United States Innova Solutions Full time

    Innova Solutions is immediately hiring for an Clinical Supply Chain Manager Full-time; Contract Location: 100% Remote As a Clinical Supply Chain Manager Professional you will: Manager, Supply Chain, is an enthusiastic team player who will provide expertise in a fast-paced pharmaceutical clinical supplies environment for Client`s global clinical trials. ...

  • Field Service Engineer

    7 days ago

    Atlanta, Georgia, United States Upm Services Inc Full time

    UPM Raflatac is looking for Field Service Engineer in the West Coast area of the United States who will be responsible for technical sales and support. You will be a member of the Americas sales team that shares the same annual targets. The Field Service Engineer will provide technical expertise and solutions to customers and end-users and supports...

  • Client Service Specialist

    7 days ago

    Atlanta, Georgia, United States Blank Label Full time

    About Blank LabelBlank Label is a renowned brand specializing in personalized men's clothing, aiming to set a new standard in menswear. Our goal is to elevate men from wearing poorly fitting attire to becoming individuals that attract compliments for their impeccable style.Established in 2010 as an online custom shirt creator, Blank Label has crafted over...

  • AT2 Material Handler Equipment Operator

    7 days ago

    Atlanta, Georgia, United States Bosch Group Inc Full time

    Job DescriptionResponsibilities will include, but are not limited to: Performs a variety of functions involved with material handling, packaging, applying correct labels, confirming part identity by comparing details, receiving, assembling and storage of parts, materials and products.Functions may include preparing parts/materials for shipment, pack...

  • Phlebotomist

    7 days ago

    Atlanta, Georgia, United States Aniz Inc Full time

    Job DescriptionJob DescriptionBenefits/PerksFlexible SchedulingCompetitive CompensationCareers AdvancementJob SummaryWe are seeking a Phlebotomist to join our team. In this role, you will collect blood, tissue, and fluid samples from patients. This is a role that can make a significant impact on peoples lives, helping them identify underlying conditions and...

  • Senior Specialist, Regulatory Affairs

    1 week ago

    Atlanta, Georgia, United States INTEGRA LIFESCIENCES HOLDINGS CORP Full time

    Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes. The Sr. Regulatory Affairs...

  • AT1 Material Handler Equipment Operator

    7 days ago

    Atlanta, Georgia, United States Bosch Group Inc Full time

    Job DescriptionResponsibilities will include, but are not limited to: Performs a variety of functions in Inbound area, Stock management area, Outbound area, involved with material handling, packaging, applying correct labels, confirming part identity by comparing details, receiving, assembling and storage of parts, materials and products.Functions may...

  • Sample Login Technician

    4 weeks ago

    Atlanta, Georgia, United States Eurofins Environment Testing Southeast, LLC Full time

    Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with...

  • Sample Login Technician

    3 weeks ago

    Atlanta, Georgia, United States Eurofins Environment Testing Southeast, LLC Full time

    Company DescriptionEurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with...