Regulatory Affairs Associate
Proclinical is currently recruiting for a Regulatory Affairs Associate with a pharmaceutical company located in San Mateo, CA.
- Responsible for preparing regulatory submissions in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Responsible for development and acquisition of required regulatory skills and knowledge.
- Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the Regulatory department.
- Performs document filing and retrieval functions as directed, or in conjunction with departmental SOPs.
Skills and Requirements:
- 1-3 years of relevant experience, a bachelor's degree or higher in a scientific field, knowledge of regulatory requirements and ICH guidelines, and experience with preparing regulatory submissions.
- 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.
- Proficiency in Microsoft Word and Excel (Power Point, Project and Visio are 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.