Why would I want this job?
Senior Manager, Regulatory Affairs for a provider of affordable, high-quality pharmaceuticals which deliver enhanced value to patients, customers and the healthcare system.
What would I be doing?
- Responsible for preparing and submitting NDA annual reports, post-approval supplements, and other submission activities in eCTD format.
- Provide regulatory assessments of CMC change controls.
- Define, prepare, and submit relevant documents required to support approvals of supplemental NDAs.
- Knowledgeable of relevant CMC regulations and FDA guidance documents.
- Maintain and update establishment registrations and drug listings.
- Maintain and update regulatory SOPs and support the review and implementation of policies and procedures.
- Provide regulatory support of state and FDA inspections.
- Act as the designated representative for company’s manufacturer and wholesale distributor licenses.
What would make me qualified?
- Bachelor’s degree in chemistry or equivalent
- Proficiency in Spanish is desirable
- 5+ years in regulatory affairs
- Strong written and oral communication skills
- Experience with Trackwise and SAP