Job Description: Senior Manager/Associate Director of Regulatory Operations

Position Overview: We are seeking a Senior Manager/Associate Director of Regulatory Operations with expertise in Veeva Vault to create and optimize submission processes. This role is strategic and hands-on, requiring collaboration across teams to ensure system compliance. The position can be remote, hybrid, or onsite, with occasional travel.

Key Responsibilities:

• Develop and manage Veeva Vault processes for regulatory submissions and archiving.
• Provide strategic and tactical support for submissions.
• Coordinate with cross-functional teams to ensure system compliance.
• Assist with regulatory submissions and archiving in Veeva Vault.
• Validate and ensure processes are fit for purpose.

Qualifications:

• Proven experience with Veeva Vault in regulatory operations.
• Strong strategic and technical skills.
• Excellent leadership and collaboration abilities.
• High attention to detail and strong communication skills.
• Availability for 20-30 hours per week.

Preferred Qualifications:

• Experience in the pharmaceutical or biotechnology industry.
• Familiarity with regulatory standards.
• Willingness to travel as needed.