Associate Director, Global Regulatory Affairs Compliance and Training Team Lead

Proven experience leading global teams and managing cross-functional projects.

Oversaw regulatory inspections, audits, and ensuring inspection readiness.

Hands-on experience with SOP governance, process optimization, and training program development.

Collaborated with internal and external stakeholders, including partners, vendors, and regulatory authorities.

Championed change initiatives and implement compliance systems or tools.

Strong knowledge of global regulatory requirements (FDA, EMA, ICH, GxP standards).

Lead the GRA Compliance & Training team, setting vision, priorities, and resource allocation aligned with corporate and GRA objectives.

Develop, implement, and maintain global compliance frameworks to ensure adherence to international laws, regulations, and corporate standards.

Oversee the GRA risk register, identify and mitigate compliance risks, and support timely corrective actions.

Manage global SOP/WI governance, ensuring harmonization across regions, optimization of processes, and adherence to local requirements.

Author, review, and approve SOPs/WIs as needed.

Lead readiness for regulatory inspections and internal audits, maintaining robust documentation and serving as RA support or lead for GxP inspections/audits when required.