Senior Specialist/Manager, Regulatory Intelligence and Analytics - Remote

Overview

The Senior Specialist/Manager in Regulatory Intelligence and Analytics will lead projects ensuring effective coordination and management of regulatory deliverables, while providing strategic input and maintaining compliance with company procedures.

In Short

• Lead and manage medium/high complexity regulatory projects.
• Perform quality control of regulatory intelligence screening.
• Provide regulatory strategic input to customers.
• Ensure compliance with company procedures and processes.
• Monitor project budgets and timelines.
• Train and mentor junior staff members.
• Foster professional relationships with internal and external contacts.
• Support preparation for audits/inspections.
• Provide feedback on vendor performance.
• Contribute to the design/review of SOPs and guidance.

Requirements

• Degree in Chemistry, Life Sciences, Nursing, or equivalent experience.
• Strong experience in pharmaceutical, CRO, or regulatory body.
• Desirable project management experience.
• Knowledge of pharmacovigilance and regulatory field.
• Good knowledge of ICH GCP and/or GVP regulations.
• Fluent in English, additional languages are a plus.
• Strong organization skills and attention to detail.

Benefits

• Training and career development opportunities.
• Strong emphasis on personal and professional growth.
• Friendly and supportive working environment.
• Opportunity to work with global colleagues.