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Regulatory Affairs Manager (06/25/09)
| Job Number: |
1456 |
| Job Category/ies: | Healthcare - Pharmacy
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| Location of Position: |
California-Los Angeles |
| Status: |
Exempt |
| Education Level: |
BS/MS |
| Salary: |
80K-120K |
| Relocation Offered: |
NO |
Job Description:
Regulatory Affairs Manager
Join a privately-held biopharmaceutical company based in Los Altos, CA pursuing the clinical development of therapeutics for diabetes, obesity and metabolic disorders. The company focuses on high value therapeutics addressing significant unmet medical needs in large markets.
The company is seeking a Regulatory Affairs Manager reporting to the VP Regulatory Affairs. The Regulatory Affairs Manager will assume responsibility for assigned Investigational New Drug Applications/Clinical Trial Applications (INDs/CTAs) to ensure submissions adhere to applicable laws, regulations and corporate standards and timelines.
Requirements
RESPONSIBILITIES
Leads the preparation of timely submissions of briefing packages, IND amendments and annual report to regulatory authorities.
Responsible for the maintenance of regulatory archives and the electronic repository for regulatory submissions and correspondence.
Coordinates the preparation and review of the companies SOPs, nonclinical, CMC and clinical documents and reports.
Works collaboratively with cross-functional project teams (CMC, non-clinical and clinical) and provides continuous regulatory advice and support.
Provides regulatory assessments for approved antidiabetic products through the review and analysis of SBA, AdCom minutes as required by the team.
Verifies quality, completeness and data accuracy of regulatory submissions.
RELEVANT EXPERIENCE
A minimum of 8 years of experience in pharmaceutical/biological product development with 5+ years in the regulatory affairs area.
Proven experience in the preparation and submission of regulatory applications, amendments, supplements and related submissions/reports.
In-depth knowledge of regulations and guidelines governing the conduct of human clinical studies, including informed consent, Ethics/Investigational Board review and CMC documentation, drug registration process (ICH, GMP, GLP, GCP) and FDA guidelines and US drug regulations.
Strong organizational skills and attention to detail.
Working knowledge of document management systems.
Working knowledge on European Centralized Procedure and Scientific Advice (EMEA).
Excellent analytical, organizational and communication skills.
Ability to audit and edit written summaries of data.
Ability to work in a flexible, multi-functional, fast-pace, multi-task team environment.
EDUCATION
BS/MS degree in a scientific discipline (e.g. Chemistry, Pharmacy, Biochemistry) required.
Send a word resume to jthompson@tescareers.com
Jeff Thompson
TES, Inc
440-266-0022 x104
Contact Information:
Contact: Jeff Thompson
Email: jthompson@tescareers.com
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