Regulatory Affairs Manager opening in San Diego
Here is an opportunity to live and work in paradise (San Diego). San Diego
County encompasses 4 climate zones with beautiful beaches, nearby mountains,
deserts and a temperate climate. When you add booming Biotech,
Pharmaceutical and Medical Device Industries San Diego is truly a paradise.
To apply for the following position contact:
Ed Morris
Sterling Resources, Inc.
edmorris from sterlingitres.com
760-732-1470
Sterling Resources, Inc. is a blended Recruiting firm specializing in the
placement of Management, Information Technology and Engineering
Professionals within the Biotech, Pharmaceutical, Healthcare and Medical
Devices Industries on a direct hire, contract and contract-to-hire basis.
Title: Regulatory Affairs Manager:
Salary 80K-95K. Will pay relocation allowance up to $10K
Qualification
* BS or MS Degree Preferred
* Minimum of 5- years' industry or closely related experience in
Regulatory affairs, Quality Assurance, Pharmaceutical development and/or
related discipline with specific previous experience as sited in the job
description below.
* Experience with Pre-Clinical Development and/or (Chemical
Manufacturing Controls)CMC.
* Electronic submission experiences a definite plus.
* Experience in transdermal drug delivery or related fields preferred.
* Direct manufacturing site experience preferred.
* Most important qualifications: Must have manufacturing experience
within the Biotech/Pharmaceutical Industry and with interactive FDA
submissions experience.
Job Description
* Responsible for filing necessary applications and handling all
government interactions pertaining to the regulation process for products
requiring governmental approval for New Drug Application (NDA).
* The collecting, monitoring, processing, and distribution of the
adverse event reports and information queries for marketed products.
* Reviews safety and medical information for the assigned products.
* Strong knowledge of FDA submission procedures and drug development
process and FDA, ICH regulations etc. Office of Generic Drugs (OGD)
* Excellent oral and written communication skills, including the
ability to discuss scientific /technical data and regulatory requirements
with senior management and FDA personnel.
* Work effectively with in team-oriented, international business
culture and demonstrate excellent planning and organizational skills in a
multidisciplinary environment.
* Ability to generate creative solutions for complex problems.
Must have some exposure in dealing with FDA directly (phone calls, etc) but
not a key contact person necessarily.
