Regulatory Affairs Specialist in Pharmaceutical Compliance
6 days ago
Foster City, CA - Fladger Assoc. Inc.
About the RoleThis Regulatory Affairs Associate position is an excellent opportunity for a detail-oriented professional to join our team in Foster City, CA. The successful candidate will have experience with regulatory compliance and be able to work under deadlines.
Responsibilities- Prepare Drug Listings/Lot Distribution Reports (Biologics) and compile documentation for Certificate of Pharmaceutical Product (CPP) requests to FDA.
- Manage Notarizations (CA licensed notary public a plus), Legalization/apostille of regulatory documents, and assist in documentation and signature preparation for License renewals and Establishment registration.
- Perform document filing and retrieval functions as directed, or in conjunction with departmental SOPs and work instructions, and disseminate information to the Regulatory Affairs CMC department.
- Participate in preparing regulatory submissions under direction of a senior Regulatory Affairs Professional, which require some interactions with other members in the Regulatory department for investigational and commercial products in line with US and ICH requirements, regional requirements and scientific and company policies and procedures.
- Assist with miscellaneous US RA CMC team-related administrative documents/activities such as processing of invoices, and participate in group meetings to address issues of moderate complexity.
- A Bachelor's Degree with a minimum of 2+ years of relevant training or industry experience preferably in a GMP environment, OR 1+ years relevant training or industry experience preferably in GMP environment with advanced degree.
- Must work well under deadlines and have excellent attention to detail.
- Strong computer and organizational skills required.
- Excellent verbal and written communication skills and interpersonal skills are required.
$90,000 - $120,000 per year, negotiable based on experience.
What We OfferThis role offers a competitive salary, opportunities for growth and development, and a dynamic work environment.
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