Summary: The Regulatory Affairs Manager II will work on a 12-month contract in a remote capacity for a leading biopharma company, focusing on regulatory systems initiatives. The role requires expertise in eCTD submission management and collaboration with global IT and cross-functional teams to enhance system implementation and quality control processes. The ideal candidate should be detail-oriented and possess strong regulatory systems knowledge.

Key Responsibilities:

• Manage eCTD submission processes and regulatory systems initiatives.
• Collaborate with global IT and cross-functional teams for system implementation.
• Oversee quality control processes, documentation, and testing.
• Provide expertise in regulatory systems to support project goals.

Key Skills:

• Expertise in regulatory systems and eCTD submission management.
• Experience working with global IT teams.
• Strong attention to detail and organizational skills.
• Ability to drive system implementation and quality control processes.

Salary (Rate): 48.00

City: Chicago

Country: United States

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: Mid-Level

Industry: Other