Associate Director, Regulatory Affairs

Location: Cupertino, CA

Career Number: 450Jun22_JB.RAAD

The Assoc. Director of Regulatory Affairs is responsible for the management of the company regulatory submissions.  The position participates in creating strategy, authoring and publishing submission for regulatory authorities. This position is ultimately responsible for the archiving of regulatory communications and submission in a manner that makes appropriate information available to specific DURECT employees for informational purposes.

Main duties and responsibilities

  • Preparation of regulatory submissions for Ex US and US registration, including IND’s, IDE’s, 510K’s, PMA’s and NDA’s and equivalent documents for Ex US.
  • Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
  • Assess proposed regulations and communicate new requirements to the organization.
  • Monitors compliance with company policies and procedures (e.g. compliance with FDA, etc.). 
  • Participate on project teams and assist/provide regulatory guidance to the project teams and in cooperation with the teams, assist in the design of regulatory strategy for the organization’s product candidates, including the manufacturing, preclinical and clinical aspects.
  • Assist VP to recommend appropriate submission structure, identify potential submission problem areas, coordinate, review, assemble and submit all new filings as well as annual reports and amendments.  
  • Review labeling, manufacturing, clinical documents and clinical sites for regulatory compliance.
  • Maintain regulatory databases of submissions and correspondence.
  • Create and maintain SOP’s as they pertain to Regulatory Affairs.
  • Provide operational expertise in the retention and archiving of specific essential documents per relevent health authority requirements (e.g., FDA, EMEA), by the principles of GCP.  These documents include externally-sourced documents from Clinical Investigators, IRB/Ethics Committee and internally-sourced documents (e.g., Clinical Protocol, IB, CSR).
  • Coordinate the distribution, retrieval, review, approval and archive of clinical and regulatory documents, including TMFs.
  • Peform with minimal supervision department related activities, including authoring, review, processing/publishing and archiving of health authority submissions and regulatory intelligence investigations.
  • Perform QA/QC audit of documents and submissions.  Review documents/submissions for conformance to ICH guidance and other regulatory directives.
  • As requested, assist other departments, including Clinical Development/Operations, QA and Document Control, Writing and Publishing.   

Requirements

Knowledge/Education:

  • BS/MS or BA degree in a scientific or health care discipline or practical hands-on knowledge of the health care industry.

Job Experience:

  • Minimum of 5 years of industry experience with working knowledge of regulatory or clinical research roles.  
  • General knowledge of GCP, ICH and FDA regulations, drug development process, regulatory affairs, project management and clinical research procedures is preferred.

Skills/Competencies:

  • High level of attention to details.
  • Excellent organizational skills.
  • Strong verbal and written communication skills.
  • Must have proficient computer skills and working knowledge of Microsoft Word, Excel, PowerPoint and MS Access as well as e-mail applications.
  • Ability to work independently, prioritize, and actively seek input within a matrix team environment.
  • Self-motivated and able to handle multiple tasks.
  • Ability to use of both hands for extended periods of time while performing regular tasks
  • Ability to lift, move and handle materials weighing up to 25 lbs unassisted

Working Conditions

  • Limited domestic or international travel may be required.


Scroll to Top