Regulatory Affairs Manager
| ID: | JLW | Type: | Contract |
| Practice Area: | Scientific | Compensation: | $50/hr+ DOE |
| Location: | New Jersey | Education: | Associate's Degree |
| City/Region: | Princeton | Status: | Full Time |
Our client is a biopharmaceutical company who is looking to hire a Regulatory Affairs Manager in Princeton, NJ. The Regulatory Affairs Manager role is a contract assignment, lasting approximately one year.
Responsibilities of Regulatory Affairs Manager:
- Provides regulatory strategic input and expertise based on regulatory guidance and experience to global project team on assigned project(s)
- Prepares routine submissions such as investigator submissions, adverse experience reports within INDs, NDAs, BLAs
- Prepares, reviews and compiles files and reports for submission to global regulatory authorities including FDA, EMA, MHRA and Health Canada
- Coordinates and maintains reporting schedules for applications in support of regulatory department
- Maintains current knowledge of regulatory standards. Assists in providing regulatory intelligence, guidances and internal policies to assure adequate and complete submissions
- Conducts regulatory intelligence searches independently and prepares summary reports describing search outcome
- Assists Regulatory Managers in the execution of regulatory plans
- Assists in departmental development initiatives
Education/ Requirements for Regulatory Affairs Manager:
- Minimum of an Associate's degree in a scientific discipline, Bachelor of Science Degree preferred
- 5 to 7 years experience independently preparing routine submissions in pharmaceutical regulatory affairs with oral solid dose, ideally both small and large molecules
- Knowledge of CMC, clinical and pre-clinical regulatory requirements
- Working knowledge of FDA/ICH guidance documents
- Global regulatory experience and regulatory experience with Biologicals and Oncology a plus
- Computer literacy necessary, preferably in MS Office applications such as Word, Excel, Access and PowerPoint
- Excellent oral and written communication skills needed. Ability to multi-task essential
- Strong critical thinking and problem solving skills
- Detail oriented with the ability to accomplish assigned objectives
