The Regional Quality and Regulatory Lead provides Group-level leadership and oversight across the Quality, Regulatory, and Pharmacovigilance portfolios for the Aventa Group.
JOB SUMMARY:
The Regional Quality and Regulatory Lead provides Group-level leadership and oversight across the Quality, Regulatory, and Pharmacovigilance portfolios for the Aventa Group. The role focuses on harmonising standards, enabling compliance, and supporting local teams across multiple markets, while ensuring that patient safety, regulatory compliance, and operational excellence are consistently upheld.
This position operates through functional (dotted-line) influence, providing guidance, escalation support, and consolidated reporting rather than day-to-day operational management.
JOB DUTIES:
Quality, Regulatory & Pharmacovigilance Oversight
- Support the alignment and integration of quality assurance, regulatory affairs, and pharmacovigilance frameworks across Aventa subsidiaries.
- Enable local teams to meet market-specific regulatory and quality requirements while maintaining Group standards.
- Monitor pharmacovigilance performance and reporting quality across markets.
Harmonisation & Continuous Improvement
- Develop and promote Group-wide templates, SOPs, checklists, and reporting tools.
- Drive consistency in product registration, storage, distribution, and post-market surveillance practices.
- Share best practices and lessons learned across markets to strengthen Group capability.
Audit, Compliance & Risk Management
- Serve as escalation point for quality or regulatory matters affecting multiple markets or regional supplier contracts.
- Support and coordinate Group-level responses to supplier, authority, or certification audits.
- Provide input on regulatory and quality risks related to new products, business development initiatives, and acquisitions.
People & Capability Development
- Provide functional guidance and mentoring to local Quality and Regulatory Officers/Managers.
- Deliver Group-wide training on GMP, GDP, regulatory compliance, and pharmacovigilance.
- Support capacity-building in markets with limited dedicated quality or regulatory resources.
ACADEMIC REQUIREMENTS:
- Bachelor’s degree in Pharmacy, Life Sciences, or a related Health Sciences field
- Registration with a relevant Pharmacy Board
EXPERIENCE:
- Minimum of seven (7) years’ experience in pharmaceutical quality and/or regulatory affairs
- Demonstrated experience operating across multiple markets or jurisdictions
KNOWLEDGE/SKILLS/ABILITIES:
- Strong understanding of Caribbean and international regulatory and quality standards.
- Proven ability to harmonise processes across diverse operating environments.
- Strong analytical, communication, and stakeholder management skills.
- Ability to influence, coach, and guide teams without direct line authority.
- Proficiency in audit preparation, compliance monitoring, and process improvement.
Open to CARICOM nationals who hold a registered pharmacy license in one of Aventa’s operating territories.