Regulatory Affairs Specialist

4 days ago

Metro Manila Philippines KUSUM HEALTHCARE PRIVATE LIMITED Full time

Job Description Review and give comments on product documents for new, renewal, and updated registrations. Prepare and submit product and company renewals, amendments, and compliance papers to the FDA and other agencies. Review marketing materials for assigned products. Make sure the company follows all regulatory rules and standards. Keep and organize product files, approvals, and registration records. Update the list of registered and renewal products. Help Sales and Marketing with product accreditation and bidding needs. Help with product inventory issues. Represent the company during FDA inspections and meetings. Lead and help with Pharmacovigilance (drug safety) activities. Attend trainings and seminars required for license renewal. Assist the RA Manager with regulatory plans and projects. Qualification Licensed Pharmacist (Bachelor’s degree in Pharmacy or Industrial Pharmacy). Well-organized and detail-oriented. Good communication, negotiation, problem-solving, and customer service skills. Experience in the pharmaceutical industry preferred. Basic knowledge of scientific and legal requirements. Proficient in Excel and Word; able to communicate clearly in writing and speaking. Can prepare and submit reports on time. #J-18808-Ljbffr

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