Senior Regulatory Affairs Specialist

This opening is located in Alameda, CA
Celera has a successful molecular diagnostics business and powerful genomic and proteomic discovery platforms that have identified and validated new drug targets and biomarkers that will advance the practice of Targeted Medicine. Celera develops and sells a growing number of molecular diagnostic products through a profit-sharing strategic alliance with Abbott Laboratories. In addition, the company is developing new molecular diagnostics and pharmacogenomic tests outside of its alliance with Abbott, and is creating additional value through collaborations based on its genomic discoveries, including new druggable targets, new indications for existing drugs, and pharmacogenomic markers for predicting therapy response. Celera is also using its high-throughput proteomics discovery platform to identify and validate novel targets in cancer. Therapeutic antibodies against these targets are being advanced through strategic partnerships.


The Senior Regulatory Affairs Specialist is responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the company. Compiles all materials required for submissions, license renewals and annual registrations to ensure the salability of Celera diagnostic products domestically. Recommends changes for labeling, marketing literature and clinical protocols for regulatory compliance to recognized standards and procedures. Keeps abreast of all regulatory registration regulations, approval processes, standards and changes. Facilitates interactions with representatives from the FDA and other regulatory agencies on defined matters to achieve approval to sell Celera diagnostic products. Recommends strategies for earliest possible approvals of products. Maintains a library of standards, guidance documents.



This position requires knowledge and skills normally acquired through the successful completion of a B.S. or M.S. degree in a scientific discipline or equivalent with a minimum of 5 years experience in a regulated industry. 3-4 years regulatory submissions work in domestic/international registrations required. Must have GMP/QSR experience. Regulatory Accreditation Certificate desirable.



Celera is an Equal Opportunity Employer.

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