Regulatory Affairs Associate
Proclinical is currently recruiting for a Regulatory Affairs Associate with a pharmaceutical company located in San Mateo, CA.
- Provides support in the preparation of routine regulatory activities for commercial or investigational products in line with ICH requirements, regional requirements, and scientific and company policies and procedures.
- Responsible for preparing routine regulatory submissions which require some interactions with others in the Regulatory department for investigational and commercial products, which may include, but are not limited to: safety reports, amendments, supplements, annual reports and aggregate reports
- Works to develop and acquire required regulatory skills and knowledge, with guidance from immediate manager.
- Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.
Skills and Requirements:
- 1-3 years of relevant training or industry experience with BS/BA.
- Strong organizational and attention to detail, along with the ability to work on a number of projects with tight timelines.
- Strong verbal and written communication skills and interpersonal skills.
- Must have a strong understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
- Proficiency in Microsoft Word and Excel.
- Experience with Microsoft Power Point and Project a plus.
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.