Regulatory Affairs Specialist

• Ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to the local authorities.
• Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• stays updated on relevant local regulations and guidelines and to develop and maintain positive relationship with key stakeholders in the regulatory environment.
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
• Maintains a positive relationship with internal and external regulatory contacts.
  

Regulatory Compliance

• Ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, packaging material and other applicable regulatory documents according to our company and local standards and relevant Artwork Management procedures.
• Ensures the correct and proper utilization of Artwork Management System to generate mock-up artwork and to implement revisions to artwork.
• Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
• Ensures that files and archives related to Regulatory are kept updated and complete.
• Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.