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Associate, ESOQ Regulatory Operations
Описание вакансии
Текст:
TL;DR
Associate, ESOQ Regulatory Operations: Supporting post-approval changes, registrations, renewals, regulatory assessments, and quality investigations in a hybrid pharmaceutical operations role with an accent on GMP compliance, dossier management, and coordination across internal functions and contract manufacturing organizations. Focus on evaluating regulatory impact, managing change records and complaints, implementing new requirements, and ensuring accurate SAP material master data.
Location: Hybrid, Makati City, Philippines
Company
develops and delivers pharmaceutical products focused on quality, safety, regulatory compliance, and patient outcomes.
What you will do
- Support post-approval changes, initial registrations, renewals, Board of Health queries, and regulatory commitments.
- Perform preliminary regulatory impact assessments, facilitate discussions, and create change management records in relevant GMP systems.
- Coordinate supporting documentation and liaise between contract manufacturing organizations and internal functions.
- Provide regulatory expertise to the Virtual Site Operating Team, including advice on regulatory strategy and potential supply constraints.
- Support dossier compliance assessments, implementation of new regulations and compendia requirements, and investigations into regulatory discrepancies.
- Manage commercial drug product, medical device, and combination product complaints, and review SAP material master workflow tasks.
Requirements
- At least 2 years of experience in a GxP setting and/or Regulatory Affairs, or 1 year with a Master’s degree.
- Expertise in change management and/or regulatory operations.
- Knowledge of US, European, and global cGMPs, compliance issues, inspectional trends, and pharmaceutical quality assurance practices.
- Proficient English and technical writing skills.
- Strong verbal, written communication, presentation, collaboration, and problem-solving skills.
Nice to have
- Experience in pharmaceutical quality assurance or quality control.
- Knowledge of regulatory requirements and guidelines or supplier quality management.
- Experience working in a matrix environment with cross-functional teams.
- Experience using generative AI tools such as ChatGPT or Microsoft Copilot, with awareness of responsible AI practices.
Culture & Benefits
- Hybrid work location assignment.
- Quality culture grounded in science, risk-based compliance, innovation, and customer focus.
- Collaborative environment based on courage, equity, excellence, and joy.