Manager, Regulatory Affairs CMC IV
770 Lindaro St San Rafael, CA 94901 | Contract
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.
- 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.
- BA/BS degree in life sciences, chemistry, molecular biology, or similar is desirable.
- Advanced degree is a plus.