Senior Manager, Regulatory Intelligence and Analytics

Role Overview

• Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables
• Perform quality control of regulatory intelligence screening of legislative requirements and ensure maintenance of the regulatory intelligence database and timely dissemination of pertinent changes
• Provide regulatory strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures
• Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
• Ensure compliance with company procedures, processes, training records, systems and any other tools
• Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated
• Monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS
• Provide support to proposal development and input to budgets, provide department representation to BD meetings as required
• Provide training, coaching and mentoring to junior members of staff
• Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery
• Participate in and/or support junior members in preparation for audits/inspections and provide department representation for assigned projects as required
• Provide feedback on performance of vendors to aid their assessment
• Provide input to department/company initiatives and contribute to the design/review of SOPs/working practice/guidance

Requirements

• Degree in Chemistry or Life Sciences, Nursing or equivalent experience
• Strong previous experience within pharmaceutical or CRO industry or Regulatory body
• Previous Project Management experience is desirable
• Knowledge of Pharmacovigilance/Regulatory field
• Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency
• Fluent Proficiency in English, both written and verbal
• Additional languages are desirable
• Strong organization skills and detailed orientated approach to work

Tech Stack

• Google Cloud Platform

Benefits

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth
• Friendly, supportive working environment
• Opportunity to work with colleagues based all over the world, with English as the company language