[Employment] Regulatory Affairs Manager opening in San Diego

[Ed Morris]

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.