Associate Director of Regulatory Affairs
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.