My client is a rapidly growing Clinical Stage, a biotechnology company in Rockville, MD pioneering the study of nucleic acid immunotherapy platforms.
Seeking a highly motivated Regulatory Affairs Associate (flexible on level) to join our expanding team and contribute to the success of our regulatory process in supporting our strategic direction.
- Assist with coordinating and preparation of documents for INDs and related regulatory submissions including amendments, annual reports, new protocol submissions, protocol amendments, safety reports, agency correspondence, etc.
- Contribute to preparing regulatory strategies for programs in various stages of development
- Assists with maintaining and archiving Regulatory documents within the document management system
- Assists with the exchange of regulatory documents between external partners and vendors involved in publishing regulatory documents
- Maintain Regulatory Submission chronologies
- Perform Regulatory Agency product approval intelligence and tracking systems.
Required Education and Experience
- Bachelor’s degree in a relevant regulatory/scientific discipline, Master’s a plus
- 2-3 years regulatory affairs experience in the therapeutic biologics vaccine area preferred
- Pre-IND and IND preparation experience with therapeutic biologics preferred
- IT capability and competence with eCTD publishing systems preferred
- Basic understanding of the drug development process
- Effectively manages multiple projects and competing priorities
- Ability to work as part of a team
- Time-management skills
- Detailed oriented
If interested in learning more please contact Heather Mudrick at heather@workforcegenetics.com