Associate Director, Global Regulatory Affairs Compliance and Training Team Lead

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Director, GRA Compliance and Training Team Lead, provides strategic leadership for the GRA Compliance & Training function, defining vision, priorities, and resource allocation to support organizational objectives. This role leads and develops a high-performing team, oversees global compliance frameworks, SOP governance, inspection readiness, and regulatory risk management. The Director drives the global training strategy, optimizes SOP processes, and collaborates cross-functionally to ensure consistent, integrated compliance standards. Key responsibilities include monitoring compliance and training KPIs, ensuring audit readiness, managing change initiatives, and fostering a risk-aware culture across GRA.

Essential Functions:

•    Lead the GRA Compliance & Training team, setting vision, priorities, and resource allocation aligned with corporate and GRA objectives. Mentor and develop team members, fostering accountability, excellence, and a risk-aware culture.
•    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.
•    Oversee compliance and role-specific training programs for all GRA staff, balancing short-term training needs with long-term career development initiatives.
•    Define, track, and report compliance and training KPIs to senior leadership and governance committees; escalate risks and issues appropriately.
•    Collaborate with QA, PV, IT, and other functions to ensure integrated compliance and training standards, knowledge sharing, and alignment of best practices.
•    Manage compliance-related change initiatives, including adoption of new systems, tools, and processes.
•    Ensure projects and products with external partners/vendors comply with relevant regulations and corporate standards, including selection and onboarding where applicable.
•    Identify and lead operational or strategic improvements to enhance compliance and training effectiveness.
•    Monitor and assess changes in regulations, industry trends, and competitive intelligence, and provide guidance on organizational impact.
•    Maintain robust documentation to support audit readiness and compliance evidence.
•    Support the management of the GRA Compliance & Training budget, ensuring effective resource allocation.
•    Participate in the selection and onboarding of GRA staff as needed to build a high-performing team.
•    Ensure alignment with Vision 2030, company Core Values, Kabegoe Principles and GRA Vision.

Requirements:

Education

Bachelor’s degree in life sciences, pharmacy, medicine, or closely related scientific discipline. Advanced degree (MS, MBA, or PhD) preferred. Relevant professional certifications in Regulatory Affairs or Compliance (e.g., RAC, CCEP) are a plus.

Experience

•    Minimum eight (8) years of progressive experience in regulatory compliance, training, or quality within the life sciences, pharmaceutical, or biotech industry.
•    Proven experience leading global teams and managing cross-functional projects.
•    Demonstrated track record in developing and implementing compliance frameworks and risk management programs.
•    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.

Technical Skills

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