Title: Senior Manager of Global Regulatory Labeling
Summary: An innovative biotechnology company pioneering drug discovery and specializing in RNA and mRNA is looking for a regulatory labeling professional to fill a new Senior Manager role at their Cambridge location. The Senior Manager of Global Regulatory Labeling will support infectious disease programs in each step of the labeling process for delivering products to new markets. The ideal candidate is a driven, creative, and forward-looking professional with experience in the pharmaceutical industry and in regulatory affairs.
The Senior Manager of Global Regulatory Labeling will be responsible for:
- Ensuring that labeling regulations and industry standards for labeling are met.
- Assisting with the production of new labeling text alongside Regulatory Strategy Leads and Strategists.
- Hands-on experience with CCDS/NDA/BLA/MAA/JNDA etc.
- Manage submissions of labeling materials and supporting documentation to regulatory agencies.
- Manage the generation of new prescribing information and changes to existing labeling.
- Oversee the labeling process end-to-end.
The Senior Manager of Global Regulatory Labeling should have the following qualifications:
- Must have Bachelor's degree; Advanced degree preferred.
- 8+ years of pharmaceutical experience.
- 5+ years of specific Regulatory Affairs and labeling experience.
- Ability to apply knowledge of science and data of assigned products to labeling.
- Experience in delivery of labeling and developing regulatory documentation.
- Ability to provide oversight to the end-to-end labeling process through excellent communication and leadership skills.
If you are interested in the Senior Manager of Global Regulatory Labeling role, then please don't wait to apply.
