Senior Manager of Regulatory Affairs
| Company | Azurity Pharmaceuticals |
|---|---|
| Location | Raleigh, NC, USA, Atlanta, GA, USA, Burlington, MA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor’s degree or foreign equivalent in regulatory affairs, biochemistry, biological sciences, chemistry, pharmacy, pharmacology, toxicology, medicine or a related life sciences field
- Three years of experience in the job offered or in regulatory affairs in the pharmaceutical industry working with 505b2 and 505j FDA applications
Responsibilities
- Provide responses to regulatory agencies regarding product information or issues
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
- Develop regulatory strategies and implementation plans for the preparation and submission of new products
- Maintain current knowledge of relevant regulations, including proposed and final rules
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
Preferred Qualifications
-
No preferred qualifications provided.