Regulatory Affairs Supervisor

Propose and implement effective strategies to minimize the timing of and optimize the commercial viability of product licenses from the relevant regulatory body.Ensure product licenses are up to date and fully compliant.Maintain strong relationships with all personnel within the relevant regulatory body to ensure ease of access and influence.Identify and analyze key regulatory issues influencing the Company’s dietary supplements and drugs and make recommendations for strategic solutions.evaluate regulatory risk and strategy for proposed new products and ingredients and manage, monitor, and support FDA filings as required and knowledgeable in QPIRA.Liaise with QA/QC, R&D, Legal, Marketing, and general management to address regulatory issues affecting product sales. Review and revise Company policies, procedures, and SOPs that impact regulatory compliance.Manage and/or participate in inspections of Company facilities by FDA and other applicable agencies.Manage and/or participate in the Company’s response to adverse event reports.Provide regulatory input on product development.Oversee the preparation of regulatory-mandated label copy for dietary supplements, to meet various regulations.Proofread and approve labels based on an understanding and interpretation of product formulas, contract provisions, account preferences and, applicable regulation policies.Review and approve product claims intended for use in labeling and advertising, in accordance with regulatory requirements.Respond to complaints and difficult issues.Prepare dossiers for submission.Bear license holder responsibility.Ensure adequate preparation for health authority meetings and, attend and provide presentations to health authorities, where necessary.Participate in quality audits.Perform other related duties as assigned.

Minimum Qualifications and Skills:

BS degree in a scientific or technical field preferably in Life sciences, Pharmacy, or engineering required.At least three (3) years’ experience in QA/QC in a pharmaceutical firm, with experience in a supervisory position is an advantage.Strong working knowledge of cGMP principlesStrong working knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical products.Experience in participating in deviation investigations, determining root causes, and developing corrective action plans.Team player with strong interpersonal, organizational, and communication skills.Willing to work in Barangay Bancal Carmona Cavite-