Regulatory Data & Systems Manager

Roles & Responsibilities:

• System Administration: Manage and maintain the organization's IT systems, ensuring they are secure, efficient, and compliant with regulatory requirements.
• Regulatory Business Analysis: Interpret and implement regulatory requirements, ensuring all systems and processes adhere to relevant regulatory requirements and industry best practices.
• Project Coordination Assist in planning, tracking, and executing departmental projects and initiatives.
• Stakeholder Communication: Liaise with internal and external stakeholders to ensure timely and accurate communication regarding regulatory requirements and system updates.

Required Knowledge and Skills:

• Strong interpersonal and teamwork skills, with the ability to interact with business users, technical IT groups, project managers, senior management, outsourced service providers, and vendors.
• 5+ years experience as a business analyst, with command of business analysis techniques & tools, as well as SDLC & agile systems development methodologies.
• Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner.
• Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction.
• Familiarity with GxP requirements and systems validation.
• Life Sciences, Biotech or pharmaceutical industry experience preferred.
• Proven Veeva Vault knowledge.

Preferred Knowledge and Skills:

• Advanced knowledge of Veeva Vault,
• Familiarity with global regulatory processes and standards.
• Proficiency in Agile methodologies, including Scrum or Kanban, to enhance collaboration, efficiency, and adaptability within an Agile work environment.

Basic Education and Experience:

• Bachelor's degree and 2 years of directly related experience
• Associate's degree and 6 years of directly related experience
• High school diploma / GED and 8 years of directly related experience