Prefer Tampa area but will consider remote for right candidate.
- Preparation of INDs/CTAs to support Phase 1-3 clinical trials. This may include writing and compiling preclinical, clinical, and administrative sections in CTD format except CMC.
- Manages IND lifecycle and maintenance activities, e.g., protocol amendments, clinical/preclinical information amendments, annual reports, DSUR’s, expedited safety reports, proprietary name requests, Pediatric Study Plans, responses to questions/information requests from health authorities, and assists in the preparation of briefing documents for milestone development meetings with regulatory agencies
- Supports the preparation of NDA’s and international marketing applications and provides strategic input on the US and global regulatory strategy
- Provides regulatory support for clinical and preclinical drug development activities (e.g., reviews clinical trial documents including clinical protocols and study reports, Investigator Brochures, Informed Consent Forms, nonclinical protocols and reports, reviews and approves clinical development plans, clinical trial material manufacturing plans and labeling, and other essential documents related to clinical trial
- In charge of the maintenance and compliance of Clinicaltrials.gov. registrations
- Applies knowledge of key guidance documents, regulations, or directives and effectively communicates any impact on drug development programs and regulatory filings
- Coordinates with cross-functional teams and interfaces with contractors, vendors, and consultants to define requirements for regulatory submissions
- Liaises with other Regulatory Affairs functions (Regulatory CMC, Operations/Documentation, and Compliance) to develop and manage timelines for the preparation of assigned regulatory filings
Education and/or Experience
- Bachelor’s degree (B.A. /B.S.) in Biology, Chemistry, Biochemistry, or related discipline.
- 6+ years of direct experience in Regulatory Affairs for pharmaceutical products
- Must have experience in preparing INDs and NDAs in CTD format
- Knowledge of FDA and ICH guidelines for drug development as well as regulatory requirements for clinical trials, investigational drugs, and marketing applications
- Strong technical writing ability
- Knowledge of eCTD content/format requirements
- Knowledge of Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and Good Manufacturing Practices (GMPs)
- Proficiency in Microsoft Office (Word, Excel, Outlook).