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Job

Senior Manager, CMC

  • Location

    Los Angeles

  • Sector:

    Life Sciences

  • Contact:

    Nikita Madan

  • Contact email:

    n.madan@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 2 months ago

  • Expiry date:

    2020-06-11

  • Startdate:

    ASAP

Senior Manager, CMC – Los Angeles

 

Responsibilities:

  • Collaborate with partner companies to address strategy and content of initial submission as well as and life cycle management of regulatory submissions (e.g. IND, CTA, NDA, and MAA).
  • Provide knowledge of global and local regulations so that regulatory submissions are in compliance with requirements
  • Identify risk areas and develop alternative plans of action through development of contingency plans
  • Ensure CMC regulatory strategy coincides with regulatory and business strategy
  • Communicate CMC changes to partner companies
  • Lead and coordinate the creation and critical review of the data packages from other representatives in order to provide complete necessary documentation necessary
  • Lead technical task force meetings leading on RA and CMC related activities.

 

Requirements: 

  • Bachelor’s degree and 8+ years of relevant experience required
  • Advanced degree (MS/PhD) and 6+ years’ experience also acceptable.

 

Additional Qualifications:

  • Organizational skills – detail oriented and can deal with frequent changes in product activity
  • High level of proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
  • High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
  • Willingness to think outside of the box and adapt best practices to our small, but growing environment
  • Ability to adapt in a constantly evolving environment
  • Familiarity with Cellular Therapy regulatory requirements in AsiaPac is highly preferred