Manager, Regulatory Affairs in San Rafael, CA at Apex Life Sciences

Date Posted: 7/18/2018

Job Snapshot

Job Description


Duties:

  • 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

Skills:

  • 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

Education:

  • BS degree (advanced degree desirable) in life sciences or experience in drug development that allows for sufficient knowledge in this area

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.