Regulatory Affairs, Market Entry Specialist

Responsibilities

• 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.

• Monitors competition by gathering current marketplace information on pricing, products, new products, delivery schedules, merchandising techniques, etc.

• Recommends changes in products, service, and policy by evaluating results and competitive developments.

• Approval of brand marketing approvals from global distribution sources

Must Have