Associate Director of Regulatory Affairs in Cambridge, MA at Apex Life Sciences

Date Posted: 7/11/2018

Job Snapshot

Job Description


Associate Director Regulatory Affairs

7/10/2018 – 1/31/2019 w/ benefits

Cambridge, MA

Pay: Open 

M-F, 8-5

Education:     

BS in science related field required, MS/PhD preferred

Chemistry, pharmacy, biochemistry is preferred

  • Lead development and execution of robust global regulatory CMC strategy
  • Work in collaboration with cross-functional CMC and Global Regulatory Teams to achieve program and company goals
  • Lead preparation, including driving strategy and content of high quality regulatory submission content focusing on chemistry, manufacturing, and control (CMC) to support global clinical development, registration, and product life cycle management
  • Manage timely regulatory submissions that involve CMC components including CTAs/INDs, NDA/MAA, and agency meeting packages.
  • Provide support to regulatory interactions on CMC related topics.
  • Actively participate in RA CMC infra-structure and capability

Skills: 

  • Minimum 8 years of experience in the pharmaceutical/biotechnology/life science industry, including at least 5 years regulatory affairs experience including managing submissions and developing regulatory CMC strategy for development and/or commercial pharmaceutical or biological products.
  • Sound understanding of chemistry and biology.
  • Experience in oligonucleotides is a plus.
  • Direct experience in preparation of original NDA/BLA, response to regulatory agency queries, and/or other complex submissions.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.