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 #02324 About our client Our client focuses on the development of therapeutic products and has programs aimed at treating gastroenterology, cancer and HIV infection. The company’s products are used to treat patients with life-threatening diseases and incapacitating conditions. It has several products candidates – both in clinical and preclinical development. Position Location Senior Manager Regulatory Affairs/Biologics New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Generate documentation to support and execute RA plans 2) Work closely with Scientific, Manufacturing and Quality personnel to support the preparation of CMC regulatory submissions, namely INDs, CTAs, etc. 3) Write, review and edit technical reports and regulatory documents 4) Coordinate and ensure effective and timely input into the planning, agreement and generation of CMC documentation 5) Review and compile dossiers for submission from matrix teams 6) Participate in discussions with the FDA and/or Health authorities 7) Write and finalize CMC sections of briefing books. 8) Participate in project teams and exercise expertise and judgment in providing guidance to other personnel on CMC issues 9) Serve as a liaison between the technical areas and external consultants 10) Keep abreast of biologics CMC requirements for antibodies, vaccines and gene therapy Requirements 1) BS or MS degree 2) 5-7 years of experience in the biotechnology, analytical or pharmaceutical technology area 3) 2 years of practical experience in regulatory affairs or related regulatory environment, particularly biologics/biotech 4) Familiarity with of cGMPs, and CMC in regulatory affairs or quality with an emphasis in the biologics/biotech area 5) Experience in clinical development requirements for cancer and HIV products and NDA/BLA preparation 6) Superb understanding of the regulatory requirements for CMC filings in the US and Europe 7) In-depth knowledge of biologics/biotech product development 8) Experience in writing and editing technical reports and investigations 9) Strong communication skills – verbal, written and listening (across multiple disciplines – both internally and externally) 10) Superb interpersonal skills 11) Excellent knowledge of the English language with strong proofing and spelling skills 12) Exceptional presentation skills, with attention to details and accuracy 13) Ability to adapt to changing priorities 14) Demonstrated ability to interact with multi-disciplined teams Strong negotiation skills 15) Ability to critically evaluate data from a broad range of scientific disciplines
Home | Our Story | Domain Expertise | Clients | Career Opportunities | Community | Contact Us
© 2006 Sterling Life Sciences. All rights reserved. Terms of Agreement.