Regulatory Affairs Associate - I
Proclinical is recruiting for a Regulatory Affairs Associate - I position with an international biopharmaceutical company located in Foster City, CA. Successful candidate will provide support in the preparation of regulatory submissions for investigational and commercial products trial applications and supplements to marketing authorizations) in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Provides support in the preparation of regulatory submissions for investigational and commercial products trial applications and supplements to marketing authorizations) in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- May be required to handle routine labeling changes and drug listing.
- With guidance from immediate manager, work to develop and acquire required regulatory skills and knowledge.
- May contribute to routine local process improvements, which have an impact on the working of the Regulatory Affairs function.
Skills and Requirements:
- Excellent organization skills and ability to work on a number of projects with tight timelines is required.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Basic understanding of role of Regulatory Affairs and regulatory requirements in a limited number of areas is required.
- May act as a resource on a specific topic for other Regulatory personnel within the department.
- Work is performed under the supervision of Regulatory Affairs professionals following detailed instruction with well-defined procedures.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Brendan Thalheimer at (+1) 215-531-5299 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.