Associate, Regulatory Affairs (Temporary) - United States
The Associate, Regulatory Affairs is responsible for the coordination, preparation and submission of a variety of regulatory submissions including INDs, CTAs, BLAs and NDAs to regulatory authorities.
- Attend project team meetings across functional areas
- Prepare, submit, and maintain domestic and international regulatory filings, both pre and post approval
- Assist with and coordinate meetings with regulatory authorities
- Assist with development strategy
- Support the filing, review, and approval of global license applications
- Support for multiple projects if necessary
- Other duties as assigned
- 2-3 years industry experience in the pharmaceutical or biotechnology industry.
- Proven ability to manage critical projects with a minimum of supervision
- Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines
- Prior experience in a product development role
- Proficient with computer and standard software programs
- Strong interpersonal and communication (written and verbal) skills
- Effective task planning and coordination abilities
- Demonstrated good judgment
- Capable of working with an interdisciplinary team
- Bachelors Degree
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.