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 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

Bachelors 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).
Expertise in compliance monitoring risk assessment and audit readiness processes.
Proficiency in training program development and learning management systems.
Familiarity with SOP/WI management document control systems and regulatory submissions.
Advanced analytical and problem-solving skills with data-driven decision-making.
Excellent communication presentation and stakeholder management skills.
Strong project management skills including resource planning budgeting and performance monitoring.
Strong proficiency MS Office Suite.

The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience skill set qualifications education (including applicable licenses and certifications job-based knowledge location and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company match
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs Sick Days and Volunteer Days
• Healthcare Benefits (Medical Dental Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long Term Incentive Program (subject to job level and performance)
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America Inc. to provide equal employment opportunity to all qualified persons without regard to race religion creed color pregnancy sex age national origin disability genetic trait or predisposition veteran status marital status sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site the personal data contained in your application will be collected and stored by Kyowa Kirin Inc. (Controller) which is located at 510 Carnegie Center Dr. Princeton NJ 08540 USA and can be contacted by emailing Controllers data protection officer can be contacted at . Your personal data will be processed for the purposes of managing Controllers recruitment related activities which include setting up and conducting interviews and tests for applicants evaluating and assessing the results thereto and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (GDPR) as necessary for the purposes of the legitimate interests pursued by the Controller which are the solicitation evaluation and selection of applicants for employment.

Your personal data will be shared with Greenhouse Software Inc. a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controllers behalf. Accordingly if you are located outside of the United States your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

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Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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