Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.  Job #02785 About our client Our client is a rapidly growing contract drug development and manufacturing company that provides complete solutions for API, prototype and final product, clinical supplies, as well as commercial production and distribution. The company has an experienced management team, a strong track record with its clients and an empowering corporate culture that is focused on the long-term professional development of its employees. Position Location Associate Director of Regulatory Affairs Southern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Provide CMC regulatory guidance on international development projects (CMC sub-teams) and for post-approval CMC changes 2) Define CMC regulatory submission strategies during development and post-approval (with substantial support and supervision) 3) Define, review and approve CMC regulatory documents from technical departments in R&D/Operations for submission to FDA and (where applicable) international regulatory authorities 4) Handle submissions to FDA for CTAA/IND and amendments, information packages for FDA meetings, MAA/NDA submissions and post-approval CMC supplemental NDA applications (CMC supplements) 5) Plan, construct and file US CMC submissions for US IND, NDA and post-approval CMC supplements 6) Provide responses to regulatory authority deficiency comments on CMC information 7) Support approval of CMC submissions 8) Provide regulatory input on strategies for addressing comments 9) Liaise with the FDA (with written communication) and participate in meetings on CMC regulatory issues 10) Create and maintain CMC regulatory document standards (Global Master Dossier) for ‘first wave’ country regulatory requirements and standards for electronic submissions 11) Promote use of GMD by Project/Product Teams 12) Maintain awareness of and develop expertise in ICH, FDA and EU guidelines (related to CMC regulatory topics) 13) Effect timely and appropriate regulatory management of CMC changes to registered products as per Corporate Change Management Procedure 14) Support Local Change Review Committees at production units in their evaluation of the regulatory impact of a CMC change 15) Evaluate regulatory impact on US NDA (e.g., Annual Report, Supplement, etc.) 16) Participate in management of investigational and market product labeling by contributing information on CMC particulars (e.g., composition, storage conditions, etc.) Requirements 1) Advanced degree in Chemistry, Biology or Pharmaceutical Science 2) Minimum 2 years of experience in a managerial role in regulatory affairs (in charge of CMC) 3) 5 years of experience in the pharmaceutical industry or regulatory agency (e.g., FDA) 4) Extensive knowledge of US and international CMC regulatory requirements 5) Ability to interpret relevance to specific development and market product regulatory issues 6) Excellent track record in direct FDA interaction and communication, including FDA audits 7) Direct working experience in filing ANDAs/NDAs using the CTD format, eCTD familiarity preferred 8) Well-organized with keen attention to detail 9) Excellent presentation, planning and communication (verbal and written) skills 10) Willingness to travel domestic and/or internationally (up to 10%)
Home | Our Story | Domain Expertise | Clients | Career Opportunities | Community | Contact Us
© 2006 Sterling Life Sciences. All rights reserved. Terms of Agreement.