Teamleader Regulatory Affairs
- Management of the Regulatory platform/ Hub team
- Contributes to recruitment of the Regulatory platform/Hub staff
- Ensures delivery of regulatory services by the platform/the Hub. Regulatory services include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers
- Serves as the senior contact for regulatory issues (backed up by regulatory colleagues as appropriate). This includes effectively liaising with clients, project/engagement managers and internal staff.
- Provides on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives.
- Provides strategic regulatory support to clients and associate companies.
- Secures the selection and qualification of regulatory partners to ensure an end to end regulatory service for the Regions/Countries under his/her responsibility. Responsible for the follow up of the quality of service of these regulatory partners.
- Ensures that invoicing is correctly set. Validate invoices.
- In liaison with IT, ensures that all tools needed to deliver service or manage projects are in place and handled by the platform/the Hub staff
- In liaison with Quality, ensures that all process and procedures supporting the service delivery are set-up and read and understood by the platform/the Hub staff
- Ensures that all technical information/ training material are organized and shared within the platform staff
- Controls data entry of the Platform/Hub staff in PLG tools. Ensures KPI, metrics for all regulatory services supplied by the platform/the hub are adequately measured and reach or exceed defined targets
- Responsible for monitoring and managing financial systems that provide accurate financial information to the Managing Director and Contracts & Finance Manager.
Bachelor’s or higher graduate degree in a science related field, or equivalent experience This experience should include a proven understanding of the regulatory process and experience in leading a project to successful completion.
- Minimum 8 year-experience in RA
- deep knowledge in MAA and post-marketing regulatory maintenance under all European procedures
- pricing and reimbursement is a plus
Key skills and competences
- Good communication skills (oral and written) in English, and Dutch and/or French
- Project management skills
- Ability to co-ordinate, manage and motivate a team
- Process orientated with good attention to detail
- Rigorous and Pragmatic
- Customer- and Quality focus
- Result driven , accurate
- Good organizational and planning skills
- Open to operate with people of different background and cultures and adapt to different work situations and work circumstances
- Flexible regarding working time and work location
- Learning attitude and continuous
- Competitive salary package
- Training and development
- International and growing company
- Dynamic environment