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:

• Bachelor’s degree.
• At least 2 years of prior experience in Regulatory Affairs at a Pharmaceutical or Biotech company.
• Understanding of regulatory requirements for drug and biological specific products is highly preferred.
• Proficient with technology that includes Windows, Microsoft Office (Outlook, Word, Adobe Acrobat, Electronic Document Management systems.