Regulatory Affairs Associate job in San Mateo, USA

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Job type: Permanent

Discipline: Officer /Associate, Operations, CMC

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Regulatory Affairs Associate with a pharmaceutical company located in San Mateo, CA.

Job Responsibilities:

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.

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