Position Title:   Regulatory Manager/ Head
Department:      Regulatory
Reports To:       CEO
Location:          Eco Tower, Taguig
 

JOB DESCRIPTIONS:

  • 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.

JOB QUALIFICATIONS:

  • 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.
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