Associate Director of Regulatory Affairs

San Francisco, California
Market Rate
Oct 02, 2018
Required Education
Bachelors Degree
Position Type
Full time

We are seeking an exceptional Associate Director of Regulatory Affairs to play a critical role in the advancement of our pre-clinical and clinical programs.

Primary Position Responsibilities

Key roles and responsibilities include, but are not limited to:

  • Author and coordinate the preparation & review of regulatory documents or submissions to facilitate marketing authorization of products.
  • Identify and ensure compliance with regulatory requirements for U.S. submissions.
  • Interpret existing and/or new regulatory requirements as they relate to company products and procedures.
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
  • Interact with the FDA and other regulatory bodies as needed.
  • Ensure regulatory inspection readiness activities and internal audits of company systems and processes.
  • Participate on product development teams to ensure US and other international regulatory requirements are incorporated as part of the development process
  • Develop, implement and maintain regulatory SOP's.
  • Maintain annual licenses, registrations and submit updates for required regulatory submissions.
  • Collaborate with team members to advance our mission to lead in the field of regenerative medicine via professional representation of the company in external meetings and communications.

Qualifications & Key Attributes:

  • Degree in scientific/related field (preferably cell biology) plus 7+ years of Regulatory Affairs experience in biopharmaceutical environment (i.e. GLP, GMP and/or ICH/GCP).
  • Prior experience in regulatory submissions, interaction with FDA reviewers/inspectors and pre-submission meetings.
  • CBER and OCTGT experience preferred.
  • RAC Certification a plus.
  • Project Management experience preferred.
  • Knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines.
  • Working knowledge of global regulations and standards including FDA, ISO, EMA, Canadian and JPAL
  • Experience with Contact Manufacturing Organizations (CMO) relating to packaging/labeling of clinical trial materials preferred
  • Attention to detail and good documentation practices, and proofreading skills with logical stepwise problem solving ability.
  • Strong problem solving, risk assessment and impact analysis abilities.