Regulatory Affairs Labeling Manager
3 hours ago
Proclinical is seeking a remote Manager, Regulatory Affairs Labeling for a global biopharmaceutical company.
Key Responsibilities:
- Lead the development of new labeling content in collaboration with a cross-functional project team.
- Manage the creation and maintenance of all US product labeling components using established labeling and artwork procedures.
- Compile labeling documents for all submissions, including labeling information and drug listing for products manufactured by the company for distribution within the US.
- Manage the compilation of labeling documents for all FDA submissions, including managing artwork revisions.
- Coordinate artwork revisions and FDA submissions.
- Maintain drug product listings and establishment registrations, and generate SPL for labeling submissions.
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.
About Proclinical:
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.
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