Position Title: Regulatory Manager/ Head
Reports To: CEO
Location: Eco Tower, Taguig
- Propose and implement effective strategies to minimize 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 impacting 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.
- 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.
- Proof-read 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.
- Manage direct reports including goals setting, budgeting, performance evaluation, coaching and mentoring.
- 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.
- Implement Quality Assurance Systems and generate Standard Operating Procedures (SOP’s) for the company.
- Perform other related duties as assigned.
- BSc degree in a scientific or technical field preferably in Life sciences, pharmacy or engineering required .
- At least three (3) years experience in QC in a pharmaceutical firm, with a minimum of one (1) year in a Supervisory position.
- Strong working knowledge of cGMP principles.
- Strong working knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical products. Experience in participating in deviation investigations, determining root cause, and developing corrective action plans.
- Team player with strong interpersonal, organizational, and communication skills.
- Good moral character.