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Job Title: Scientist/Manager, Regulatory Affairs
Description:
Candidate will actively contribute to the development and implementation of regulatory strategy for specific projects by identifying and assessing regulatory risks and coordinating all aspects of regulatory submissions with a focus on CMC.
Responsibilities include planning, writing, coordinating and reviewing CMC documentation/data to support regulatory submission activities for IND/CTA and NDA/MAAs (including IMPD Quality Section) and amendments/supplements/variations there to; ensuring the quality and content of all CMC submissions to global health authorities; ensuring adherance to global regulatory requirements; contributing to the development of comparability, validation, and stability protocols for global regulatory compliance.
Candidate will also participate in various cross-functional project teams and have close interactions with the Pharmaceutical Development and Quality Assurance both within Cougar as well at the manufacturing sites; assess and communicate CMC regulatory requirements to the product development teams to ensure all development activities are in compliance with applicable regulations and guidelines; provide global regulatory assessments for anticipated CMC changes; monitor changes to development plans and provide regulatory guidance to bridge changes.
Qualifications:
Candidate must possess a BS in Chemistry or related science (biochemistry, biology, pharmacy, microbiology) and a minimum 3-5 years of regulatory experience, with an emphasis on CMC strategy and submissions, in the biotech/pharmaceutical industry. Experience and solid knowledge of relevant U.S., EU regulations/directives and guidance (including ICH guidance), as well as familiarity with the overall drug development process and regulatory CMC expectation throughout all development phases are a plus. Requirements also include excellent written/oral communication skills; proficiency in MS Word and electronic document management systems; familiarity with CTD and eCTD application requirements and processes.
Compensation:
Commensurate with experience
Date Posted: 04/10/2008
Email Résumé to info@cougarbiotechnology.com
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Cougar Biotechnology, Inc.
10990 Wilshire Blvd, Suite 1200
Los Angeles, CA 90024
(310) 943-8040 Main
(310) 943-8059 Fax |
