Associate Director, Regulatory Affairs - Costa Mesa, CA

Scope of the Job:

This position, located at the Company Headquarters in Costa Mesa, CA reports to the Vice President of Regulatory Affairs. Your basic role is to provide hands on regulatory expertise, professional management and leadership necessary to guide the R & D and Clinical Programs toward successful compliance and approvals. You will be responsible for IND, NDA and BLA submissions and R&D driven line-extensions supplements from Pre-submission to approval of product/application. Responsible for addressing data requirements to regulatory authorities. Provides regulatory scientific and technical expertise into the global development plans. Prepares for and expedites early and effective approval of pharmaceutical new products in global accordance with regulatory strategy. You will also be responsible for the review of chemical/pharmaceutical, pre-clinical and clinical research reports. Represents company wide regulatory interests by meeting with regulatory agencies and through participation in relevant conferences, etc. Provides expert regulatory advice to internal Clinical Research divisions to ensure compliance with FDA regulations and successful NDA, IND & BLA submissions. Finally, you will effectively communicate and implement determined strategies with the appropriate departments and/or employees. Work to minimize regulatory issues and help prevent unnecessary regulatory delays. You will train staff in the preparation of documentation for regulatory review in technical areas in cGMPs, and performs regular evaluations; performs related duties as assigned.

Candidate Requirements:

· A bachelor’s degree in a scientific discipline and 6 - 10 years of regulatory experience in a pharmaceutical or biotech company.

· Must have direct hands on experience preparing and filing IND, NDA & BLA submissions and representing Company product lines to FDA and regulatory agencies (CDER preferred but CBER is acceptable).

· Must have thorough understanding of good clinical/laboratory or manufacturing practices, regulatory compliance and statistical reporting.

· Must possess the understanding of scientific methods and the ability to interpret and communicate scientific data to the FDA.

· Must have excellent PC, written and verbal communication skills.

· Supervisory experience is required.

Compensation

A compensation package will be designed to attract outstanding talent and will include a base salary, performance bonus, and an attractive benefits package.