Regulatory affairs associate Jobs in Lake forest ca

Pharmaceutical or Biotech Submission Experience Only (NO MEDICAL DEVICE)

Responsibilities :

• Act as the point person from Regulatory Affairs in meetings, closely collaborating with cross-functional teams to identify submission requirements, and accurately coordinate content.
• Arrange regulatory submissions that meet ICH or FDA requirements.
• Oversee detailed timelines to ensure timely delivery of high-quality regulatory submissions.
• Develop and rollout submission document SOPs to track and manage product-associated events.
• Evaluate regulatory history and therapeutic area context to assist in assessing regulatory implications for development and approval.
• Remain updated on changes to the regulatory environment and guidelines (e.g., FDA, ICH) in relevant to company wide projects.

Requirements :