Director of Regulatory Affairs

3 days ago


Redwood City, United States MFS Talent Full time
  • Shift: Days - 8 hours, Monday-Friday, 40hrs/week
  • Location: Onsite, Palo Alto, CA
  • Compensation: $180k-$230k annually


Duties and Responsibilities

  • Responsible for strategic and operational regulatory input and support for collaboration with other project team members, including regulatory team members.
  • Contributes to the development of regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
  • Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
  • Prepares and/or manages submissions that may be technically complex and require extensive interaction with departments outside of regulatory affairs.
  • Provide regulatory advice and information to cross-functional teams and to other functional areas (i.e., CMC, nonclinical, and clinical) for product development and planning to support the timely achievement of company and department goals.
  • Leads the drafting, review, and finalization of responses to queries from Regulatory Authorities
  • Maintains knowledge of regulatory requirements up to current date and communicates changes in regulatory information to other departments.

Education Qualifications

  • A degree in a life science, chemistry, or chemical engineering or closely related discipline with a graduate degree preferred


Experience

  • At least 10 years of experience in pharmaceutical regulatory affairs, that includes, but cannot be limited to, CMC regulatory affairs.



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