Manager, Regulatory Affairs CMC IV

San Rafael, CA 94901 | Contract

Post Date: 07/30/2018 Job ID: 4553 Industry: Regulatory Affairs & Compliance

Our client  focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

 

Duties:
  • Coordinating the planning, preparation and submission of global regulatory CMC-related submissions for clinical and commercial products such as: post approval variations, Marketing Application(s), Annual Reports, Clinical Trial Applications, and amendments.
  • Developing and/or reviewing regulatory documents to ensure that all submissions are complete, accurate and meet relevant requirements.
  • Creating timelines and tracking deliverables to timelines to ensure that all submissions are submitted on-time.
  • Performing regulatory research and drafting reports summarizing regulatory requirements.
  • Proactively identifying issues and suggesting appropriate strategies to mitigate risks.
  • Ensuring consistent and appropriate communication within the department and with other functional areas.
  • Interfacing with global Regulatory partners, internal cross functional teams, and consultants.
  • Assisting in the preparation for meetings with global regulatory authorities.
  • Attending relevant functional area and project team meetings.
  • Develop excellent relationships with internal functional groups, contract manufacturing organizations, and corporate partners.

 

Skills:

  • At least 5 years of experience in Regulatory Affairs or a related function such as Quality, Process Development in a global pharmaceutical and/or Biotechnology Company (preferably with exposure to biologic products).
  • Thorough understanding of relevant drug development regulations and guidelines (ie, FDA regulations and ICH guidelines) as well as an understanding of CGMP.
  • Outstanding interpersonal and communication (written and verbal) skills is required.
  • Strong writing and editing skills for technical documentation.
  • Experience with devices or combination products a plus (ie, HFA evaluations, FMEAs).
  • Effective task planning and coordination abilities.
  • Proficient with computer and standard software programs.

 

Education:

  • BA/BS degree in life sciences, chemistry, molecular biology, or similar is desirable.
  • Advanced degree is a plus.
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