Regulatory Labeling, Advertising and Promotion Manager - Atlanta, United States - UCB S.A.

Description

Make your mark for patientsRegulatory Labeling, Advertising and Promotion ManagerWere 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 youll work with:

Collaborate with Supply Chain to coordinate implementation strategy for new labeling artworkInterface 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 teamI nterested? For this role were 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.

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.#J-18808-Ljbffr