Regulatory Affairs, Market Entry Specialist
A fantastic opportunity has become available for a Market Entry Specialist to join our Quality and Regulatory Affairs department in the execution of regulatory activities.
Collaborating closely with the Administration, Regulatory, Sales and Finance departments in order to ensure timely submission to regulatory Agencies.
Providing strategic and operational regulatory support in preparation of the submission and during the review of new Marketing Authorisation Applications, variations and all other regulatory activities in order to secure agency submissions and approvals in compliance with applicable regulatory requirements of each country.
Preparing quality documentation and reports by collecting, analysing and summarising information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
Developing and writing clear arguments and explanations for new product licences and licence renewals;
Keep up to date with regulatory requirements and legislation and ensure updates to regulatory databases.
Monitor competition by gathering current marketplace information on pricing, products, new products, delivery schedules, merchandising techniques, etc.
Recommend changes in products, service, and policy by evaluating results and competitive developments.
Approval of brand marketing approvals from global distribution sources
A university, bachelor’s degree or equivalent in life science,
Ability to take on diverse tasks, with a results driven approach.
Outstanding communication skills
Great attention to detail and a results driven approach
Excellent organisational and leadership abilities
Integrity and a professional approach to work
Strong appreciation of both legal and scientific matters
Ability to work under pressure and to strict deadlines
Fluent in English.
Permission to work in Belgium.