Manager, Regulatory Affairs Labeling – Permanent – Georgia, North Carolina or Massachusetts
Proclinical is seeking a remote Manager, Regulatory Affairs Labeling for a global biopharmaceutical company with locations in Georgia, North Carolina and Massachusetts.
Primary Responsibilities:
In this role, you will will lead development of new labeling content in collaboration with a cross functional project team. You will manage the creation and maintenance of all US product labeling components using the established labeling and artwork procedures in collaboration with the assigned product Regulatory Leads, Regulatory Labeling as well as Advertising and Promotion Scientist Leads. You will also manage the compilation of labeling documents for all submissions which include labeling information as well as be responsible for drug listing for product manufactured by the company for distribution within the US as well as establishment registration.
The position can be based at any of their US sites (Georgia, North Carolina, Massachusetts) in a hybrid work environment (2 days per week onsite).
Skills & Requirements:
- Bachelor’s degree or higher
- At least 5 years of relevant experience in the pharmaceutical industry with preferably 3 years in Regulatory Affairs and specific experience in US Labeling
- Knowledge of US labeling regulations and guidance
- Knowledge of science and data of assigned products and how that translates into labeling language
- Product launch experience preferred
The Manager, Regulatory Affairs Labeling will:
- Develop and maintain knowledge of US labeling regulations and industry standards
- Direct the labeling control process for changes to existing labeling
- Ensure consistency with the Global Labeling Function (GLF) and CCDS
- Manage Labeling Review Committee (LRC) packages and approvals
- Compilation of required labeling documents for all FDA submissions, including managing any artwork revisions
- Coordinate artwork revisions and FDA submissions
- Maintain drug product listings and establishment registrations; manage generation of and generate SPL for labeling submissions
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com.
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.
