SUMMARY/JOB PURPOSE:

Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Review clinical site regulatory documents to provide Regulatory approval to ship investigational product.
  
  


• Regulatory document archival into electronic system
  
  


• Track safety reports and coordinate submissions to US INDs.
  
  


• Assist Project Team Regulatory Representative in preparing routine IND submissions and ex US clinical trial applications, tracking submission progress, and archiving regulatory submissions and correspondence.
  
  


• Manage portfolio timelines in collaboration with Regulatory Operations and Regulatory Affairs staff to effectively enable a robust regulatory submissions calendar.
  
  


• Facilitate the internal review and approval process for regulatory submissions.
  
  

SUPERVISORY RESPONSIBILITIES:

• No direct supervision in role
  
  

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

EDUCATION:

• AA degree in related discipline and three years of related experience; or,
  
  


• BS/BA degree in related discipline and one year of related experience; or,
  
  


• MS/MA degree in related discipline and related experience
  
  

Experience:

• Typically requires a minimum of two years of related experience and/or combination of experience and education/training in regulatory affairs.
  
  


• Knowledge of US and ex-US regulations and guidelines.Knowledge/Skills:
  
  


• Organizes and prioritizes numerous tasks and completes them under time constraints.
  
  


• Frequently applies technical standards, principles, theories, concepts and techniques.
  
  


• Performs a variety of tasks with a wide degree of creativity and latitude.
  
  


• Resolves a wide range of issues in creative ways.
  
  


• Applies strong communication skills.
  
  


• Has good general knowledge of other related disciplines.WORKING CONDITIONS:
  G&A and Development/Alameda:
  
  


• Environment: primarily working indoors, performing clerical work
  
  

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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