Regulatory Policy Specialist developing regulatory case filings and strategies supporting company goals at Xcel Energy. Collaborating with stakeholders and senior management to ensure compliance and effective communication.
About the role
- Lead Compliance and Risk Management at Galderma to ensure quality and regulatory standards. Foster global compliance strategies and team development in a hybrid workspace.
Responsibilities
- Provide global leadership for GxP compliance, regulatory readiness, and risk management across manufacturing, R&D, supply chain, quality control, and affiliate operations.
- Define, implement, and continuously improve global compliance policies, procedures, and standards, ensuring harmonized application across regions and sites.
- Lead the global audit and inspection readiness strategy, including internal audits, supplier and third-party audits, mock inspections, and inspection preparedness activities.
- Oversee global readiness and execution for health authority inspections (FDA, EMA, MHRA, PMDA, WHO, and other authorities).
- Govern global deviation, CAPA, and critical issue management processes, ensuring timely investigation, root cause analysis, effectiveness checks, and appropriate escalation of major risks.
- Build, lead, and develop a high-performing global Compliance & Risk Management team, fostering a culture of accountability, transparency, and continuous improvement.
Requirements
- Master’s degree in Pharmacy, Biology, Chemistry, Biotechnology, Engineering, or a related scientific discipline; advanced degree (MBA, MSc, PhD) preferred
- 10+ years of experience in pharmaceutical, biotech, or medical device environments, with a strong background in GxP compliance, audits, inspections, and quality risk management.
- Proven experience leading and managing global health authority inspections, including FDA and EMA; experience with MHRA, PMDA, WHO, or PIC/S is a strong advantage.
- Strong knowledge of global pharmaceutical regulatory environments, quality systems, and compliance governance.
- Experience overseeing digital quality and data integrity programs, including CSV/CSA, audit trails, and validated GxP systems.
- Excellent analytical, problem-solving, and decision-making skills, with a proactive and risk-based mindset.
- Fluency in English; additional languages are an advantage.
Benefits
- competitive compensation package with bonus structure and extended benefit package
- hybrid work culture
- personalized career path establishment
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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