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Manager, Regulatory Affairs CMC IV
Ref No.: 18-11709
Location: San Rafael, California
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.

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.