Job Description:
Responsibilities/ Skills:

• 10 years of experience working on regulatory submissions in biologics. They will support a range of activities from technical report review, submission authoring and review of submissions, annual reports
• Prior experience in regulatory affairs, regulatory CMC, audit, compliance or investigation/CAPA role; prior work on regulatory filings and supporting technical reports for module 3
• Prior experience in a quality assurance or quality systems role in a biologics manufacturing operation, or similar
• Ability to manage multiple products, submissions and reviews in a matrixed team; strong eye for detail and experience in analytical methods development or quality control role.

Education:

• Bachelor's degree in Science or Engineering

Job Types: Full-time, Contract

Pay: $66.60 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

Work Location: Remote