Regulatory Data & Systems Manager

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

Preferred Education and Experience:

• Practical experience with regulatory data standards, such as IDMP

• 5+ years' experience in administering large scale enterprise systems in the Biotech/Pharmaceutical industry

.