Manager/Director, Technical Regulatory managing regulatory submissions for pharmaceutical products. Ensuring compliance with local and global standards in order to support timely approvals.
About the role
- Regulatory Data Coordinator managing activities within V-RIM process in Colombia. Leading complex projects and ensuring data accuracy in regulatory submissions.
Responsibilities
- Develops ideas and leads/co-leads complex projects across RIO, G&IPE & GRS.
- Develops and manages plans to achieve objectives
- Applies skills and discipline knowledge to contribute to the achievement of work within Sub Business Unit/Sub Operating Unit
- Makes decisions that require developing innovative options to resolve complex problems
- Leads operational team(s) within and across Work Teams and Departments
- Management of all related RIM events and their related records
- Interpret communications and drive appropriate actions to update system
- Evaluate and approve data change requests
- Ensuring maintenance across the lifecycle
- Train & support business users on data quality standards and data & process management best practices.
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Regulatory Affairs, Data Management, or related field.
- 6+ years of experience in Regulatory Affairs or Regulatory Operations, with at least 3 years in a data governance, data management, or data quality role.
- Significant experience with master data management and data quality improvement.
Benefits
- EEO (Equal Employment Opportunity) & Employment Eligibility
- Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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