What you will be doing:
This key role is involved in the management of multiple Investigational New Drug (IND) applications and international regulatory filings to support Phase 1-3 drug development programs. This individual will also support the preparation and submission of US New Drug Applications (NDA's) and international marketing applications.
- Assists in the preparation of INDs/CTAs to support Phase 1-3 clinical trials including IND maintenance activities, e.g., protocol amendments, clinical/preclinical information amendments, annual reports, DSUR's, expedited safety reports, 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 manufacturing plans and labeling, and approves drug shipment to clinical sites
- 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
- Contributes to the development and implementation of processes and standards for the Regulatory Affairs Department
Experience you will need:
5 years of direct experience in Regulatory Affairs managing IND's and NDA's
- Knowledge of FDA and ICH guidelines for drug development as well as regulatory requirements for clinical trials, investigational drugs, and marketing applications
- Knowledge of eCTD content/format requirements
- Knowledge of Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and Good Manufacturing Practices (GMPs)
- Ability to read, analyze, and interpret scientific, technical data, and regulatory guidelines and regulations.
- Proficiency in Microsoft Office (Word, Excel, Outlook).
- Ability to work independently or as part of a team; displays a commitment to service, be process oriented, and have a sense of urgency balanced with good judgment
- Able to build relationships with clients and co-workers.
- Demonstrated ability to deal with confidential information.
- Individual will be a professional who is able to prioritize multiple and changing responsibilities while being organized & detail oriented.
- Able to display effective interpersonal skills with all levels of employees, from a variety of different backgrounds and cultures, as well as the ability to positively and effectively communicate, verbally and in writing.
- Strong integrity and work ethic are critical.
- Ability to build relationship with clients and co-workers.
- Able to anticipate problems.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Bachelor's degree (B.A. /B.S.) in Biology, Biochemistry, or related discipline.