Regulatory Affairs Specialist

• Works under moderate guidance and is responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the Company.
• Compiles materials required in submissions, license renewals and annual registrations.
• Keeps abreast of regulatory procedures and changes.
• Coordinates the collection of documents, records, reports, and data from the Development, Clinical Affairs, Quality, and Operations Departments for inclusion in regulatory documents.
• Assists in the preparation of international registration dossiers for use in international registration of our client's Affiliates.
• Support countries' requests.
• Participates with internal/external teams and builds professional relationships.
• Identifies and suggests solutions to Regulatory tasks.

Requirements:

• To perform this job successfully, an individual must be able to perform each responsibility satisfactorily.
• The requirements listed below are representative of the knowledge, skills, and/or abilities required.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
• 5 years of related Regulatory Affairs experience.
• Bachelor's Degree preferred.