Regulatory Affairs Specialist (Labeling)
A global biopharmaceutical corporation in New Jersey is looking for a Regulatory Affairs Specialist for their Regulatory labeling division on a 1-year contract basis.
The Regulatory Affairs Labeling Specialist will be responsible for: 1) partnering with Global Regulatory Strategy Leads and CCDS Teams in the development and maintenance of Company Core Data Sheets for assigned products. 2) Partner with Regional Regulatory Strategy Leads in the development and maintenance of US prescribing information. 3) Assist in the development of labeling strategy, including contingency strategy for negotiation with FDA. 4) Work with cross-functional teams to ensure that desired label statements will be adequately supported by submission documents. 5) Ensure that draft labeling complies with all applicable regulations and guidelines. 6) Train Regulatory Affairs staff and other functions on labeling regulations, guidances, and processes. 7) Update CCDS records and databases & conduct labeling audits.
Duration: 12-month contract
Location: Summit, New Jersey
Compensation: $55-62 per hour
- Education: Bachelor's degree in pharmacy or other scientific discipline. Advanced degree preferred.
- Regulatory labeling experience or equivalent required
- Must have 4-8 years of previous pharmaceutical industry experience
- Thorough understanding of US labeling regulations; good understanding of the drug development process is required
- Familiarity with global labeling regulations
- Excellent communication (oral, written) and presentation skills necessary for interaction with cross-functional product labeling teams
- Excellent editing skills
- Detail oriented & strong interpersonal skills
Sthree US is acting as an Employment Business in relation to this vacancy.