Regulatory Operations Associate
Proclinical is currently recruiting for a REMOTE Regulatory Operations Associate with a pharmaceutical company located in Princeton, NJ.
- Facilitate all aspects of US drug listing compliance including content of Labelling/ SPL Generation, review, submission, updates to listing with new artwork, labeler codes, establishment registrations, etc.
- Assist in data migration and integration activities, as well as maintenance of all regulatory documents, and records in a controlled environment.
- Proofreads internal and external material to ensure accuracy of labelling content and company format.
- Strong drug listing expertise.
- Documentation management experience.
- Attention to detail, with excellent organizational, interpersonal and communication skills, both written and verbal.
- Clear communication.
- Experience with A4L or other third-party vendor software a plus.
- Ability to multitask, work independently and remotely within set timeframes.
- Performs related duties as assigned.
Skills and Requirements:
- Bachelor's degree required. Advanced degree preferred.
- 4 years pharmaceutical industry experience.
- Experience with OTC products a plus.
- Remote position but must work in Eastern Standard Time.
If you are having difficulty in applying or if you have any questions, please contact Catherine Nguyen at 215-531-5643.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.