Sr. Regulatory Operations Specialist - San Diego, CA | Biospace
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Sr. Regulatory Operations Specialist

Therapeutics, Inc.

Location:
San Diego, CA
Posted Date:
9/5/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Regulatory Affairs,

Job Description

PRIMARY OBJECTIVE OF THE POSITION:  
The primary duties of this position are to compile, publish and submit eCTD compliant regulatory dossiers to the FDA and other health authorities in a timely manner, and provide Regulatory support to project teams.
MAJOR RESPONSIBILITIES AND DUTIES:
•   Plan, compile, publish and submit Regulatory documents for IND, NDA, BLA, IDE, and PMA applications, including Amendments, Supplements, and Meeting materials to the FDA.
•   Review submission components for quality and completeness.
•   Assure all electronic submissions are in compliance with regulatory requirements and ICH eCTD specifications.
•   Maintain Regulatory submission and correspondence archive/records.
•   Provide publishing support to the Medical Writing group, as requested.
•   Provide regulatory support to other departments, as requested.
•   Assist Regulatory Director in providing regulatory strategy, intelligence, and other regulatory support to product development teams.
•   Serve as a point of contact for the FDA.    

Requirements

QUALIFICATIONS:
The candidate should have a BS degree preferably in a scientific discipline (or equivalent knowledge and experience) and a minimum of 3 years’ experience in Regulatory Operations/electronic submissions.  Technical knowledge in eCTD compliant submissions and experience with off-the-shelf publishing software is highly desirable.

Good understanding of FDA’s submission requirements and drug/biologic/device development processes is required.  Good oral and written communication skills, detail-oriented, self-directing, and ability to handle multiple projects across all functional areas independently are essential.