Address
Form of workJob Description
Salary:
- General Responsibility Specific Responsibilities
- 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.
- Ensure the on-time submission of all postmarketing reports.
- Develop and prepare CMC-related submission documents in accordance with current regulatory standards ensuring high quality and first review cycle approval.
- Understand regulatory lifecycle management of NDAs in eCTD format ensuring files are up to date and accessible to FDA.
- Work independently, proactively, and cross-functionally with internal and external team members.
- Maintain in-depth understanding of relevant regulatory guidelines.
- Education: Bachelor’s degree in Chemistry or equivalent
- Languages: Fluent in Proficiency in Spanish is desirable.
- Personal skills: Strong written and oral communication skills.
- Experience with Trackwise and SAP desirable.
- Personal skills: Strong written and oral communication skills
