Regulatory Affairs

Regulatory Affairs Specialist:Must be a licensed Pharmacist with at least 2 years experience with regulatory affairs within Pharmaceutical industryAt least 1 year exposure to Pharmacovigilance and FDA promo permit submissionKnowledgeable in regulatory requirements for consumer health productsMust be proficient in MS Word, Excel, and OutlookDetail oriented...

Assisting in the preparation and submission of documentation required for FDA drug registration and MAH (Marketing Authorization Holder) license acquisition.Coordinating with regulatory consultants throughout the licensing process to ensure compliance with relevant regulations.Supporting legal and regulatory compliance efforts, including proper documentation...

Quality Management and Regulatory Affairs SupervisorThe Quality Management and Regulatory Affairs Supervisor serves as the Deputy to the Quality Management Manager and holds primary responsibility for the deliverables and outputs of both the Quality Management and Regulatory Affairs sections. This role ensures the timely and accurate registration of the...

JOB OVERVIEW:The Regulatory Affairs Specialist is responsible for managing all regulatory affairs, documentation, and follow-up transactions with the FDA and LGUs. He/She ensures that all company products comply with legislative requirements, secures and maintains updated permits and licenses, and oversees Grifols logistics.TASK LIST:RA CompliancePermits &...

Job Summary:The Regulatory Affairs Manager is responsible for ensuring that the company's products meet all regulatory requirements and standards in the markets where they are sold. This role involves managing the regulatory approval process, keeping up to date with regulatory changes, and ensuring compliance with all relevant laws and guidelines. The...

Regulatory Specialist:· Must be a licensed Pharmacist with at least 2 years experience with regulatory affairs within Pharmaceutical industry· At least 1 year exposure to Pharmacovigilance and FDA promo permit submission· Knowledgeable in regulatory requirements for consumer health products· Must be proficient in MS Word, Excel, and Outlook· Detail...

We are looking for an experienced and detail-oriented Regulatory Affairs (RA) and Quality Assurance (QA) Manager to lead the implementation of company-wide quality systems and ensure full compliance with regulatory requirements.This critical role involves managing audits, maintaining product quality, overseeing documentation, and serving as the primary...

Job Summary:The Regulatory Pharmacist will be responsible for ensuring compliance with Philippine FDA regulations and other applicable laws governing the registration, licensing, distribution, and marketing of pharmaceutical products. The role involves preparing and submitting regulatory dossiers, securing necessary permits, and monitoring regulatory changes...

Duties & ResponsibilitiesAssist in preparing all the technical documents required for submission to FDA and other regulatory agenciesResponsible for ensuring that all product registrations, licenses, and certificates are valid and submitted to the FDA for renewal prior to the expiration dateUpdate and monitor the registration status and validity date of all...

QUALITY ASSURANCE:Responsible for the final release of products in the absence of Sr. RA/QA Manager.Responsible for ensuring that all third-party suppliers comply with GMP and RGDI Quality StandardsSupervise and direct quality assurance technicians/auditors who are responsible for enforcing Good Manufacturing Practices and other quality-related policies in...