Company Pharmacists

JOB QUALIFICATIONS:

Be a licensed pharmacistHave between 3- and 5-years relevant experience and a proven track record in regulatory work.Possess a solid knowledge of the regulations in, systems and procedures within the FDA.Have excellent oral and written communication skillsExhibit competencies in Leadership, Communications and Teamwork and Strategic Focus.

JOB RESPONSIBILITIES

Liaise with FDA on all matters relating to registrations, licenses, permits and interrelations.Establish systems and procedures in the creation and maintenance of product dossiers for existing and future products.Ensure product quality as it relates to development, manufacturing and pharmacovigilance.Co-own training of new hires.

Key Tasks:

Prepare, evaluate, and submit all required documents for timely registration of new and renewal products to BFAD.Prepare, evaluate and submit all required documents for renewal of LTO.Oversee the development of Operational Procedure for the inspection process in line with the standards and guidelines of FDA.Ensures adherence and compliance with FDA guidelines and regulations.Collect and prepare pharmacovigilance reports for submission to all relevant authorities.Provide technical assistance in the development of new products and coordinate and cooperate with new product development partners.Conduct regular review of printed materials such as, but not limited to packaging, stickers, product literatures and the like.Work closely and regularly with toll manufacturers to ensure highest standards of product efficacy and safety.Inspects manufacturer establishments to monitor their compliance to set standards of Good Practice and FDA mandates.Participate in preparation of training modules specifically in pharmacology and other technical aspects of the product training to newly hired employees.Performs other job-related duties as mandated by the Business Lead.