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Manager, Regulatory Affairs
Ref No.: 18-09311
Location: San Rafael, California
Oversee planning, preparation, and submission of marketing applications
Oversee planning, preparation, and submission of INDs and international equivalents
Oversee IND maintenance and the submission of all amendments
Provide strategic insight to the project team regarding product development, with emphasis on US strategic considerations.
Communicating with regulatory consultants regarding product development plans
Manage interactions and relationship with FDA or other regulatory authorities as assigned
Potential for management of additional employees
Other duties as assigned

4 plus years experience in Regulatory Affairs in the biotechnology industry
Skilled at gathering regulatory information and developing product approval strategies
Proven ability to manage critical projects as a part of a interdisciplinary team
Proven ability to successfully interact with regulatory authorities, including leading the preparation of key regulatory meetings.
Prior experience serving as primary sponsor contact for FDA. Experience interacting with ex-US authorities highly desirable.
Prior experience leading the development of complex briefing documents
Prior experience managing regulatory submissions with the ability to successfully manage projects to deadlines
Thorough understanding of relevant drug development regulations and guidelines
Proficient with computer and standard software programs
Outstanding interpersonal and communication (written and verbal) skills
Effective task planning and coordination abilities