Regulatory Affairs Manager Job in Cheshire, North West UK
Key Requirements
• Previous experience managing/leading team
• Experience in pharmaceutical regulatory environments of US/EU and international markets
• Degree qualified in Chemistry or Life Sciences
• Knowledge of CGLP, CGMP regulatory requirement
• Knowledge of pharmaceutical product development processes
• Experience of regulatory project management
Key Responsibilities
• Plan, resource, manage and co-ordinate the delivery of projects to support the achievement of product launches and variations.
• Monitor and control departmental spend in line with agreed budget.
• Recruit, select, develop and motivate individual and team performance using communication, appraisal and HR systems.
• Ensure site licences are kept current and reflect the activities performed on site. To provide leadership and guidance to ensure site activities comply with regulatory requirements.
• Prepare and review high quality regulatory documents for submission.
In summary the successful candidate will have at least five years experience in Regulatory Affairs at management level and be degree qualified in a Life Science or Chemistry subject.