Regulatory Affairs Associate
Proclinical is currently recruiting for a Regulatory Affairs Associate with a global pharmaceutical company located in Foster City, CA. Successful candidate will have past preparing regulatory submissions experience.
- Prepare routine regulatory submissions which require some interactions with others in the Regulatory department for investigational and commercial products in line with ICH requirements, regional requirements and scientific and company policies and procedures.
- Organize submissions, which may include, but are not limited to: safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations.
- May provide input to the development of labeling and submit labeling changes, and drug listing.
- Participate in group meetings and provide tactical approaches to addressing problems of moderate complexity.
- Responsible with manager for development and acquisition of required regulatory skills and knowledge.
- Act as a resource on limited topics within the department.
- Contribute to local process improvements, which have an impact on the working of the Regulatory Affairs function or other departments.
Skills and Requirements:
- Bachelors/Master's degree.
- Pharmaceutical experience is a plus.
- Experience with Regulatory submissions.
- Excellent organization skills and ability to work on several projects with tight timelines is required.
- Excellent verbal and written communication skills and interpersonal skills are required.
- Must have a reasonable understanding of regulatory requirements, including ICH requirements and regional requirements for assigned territories.
- Work is performed under the general supervision of more senior Regulatory Affairs professionals.
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 Catherine Nguyen at (+1) 215-531-5643 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.