Title:  Senior Manager, Regulatory Compliance

POSITION SUMMARY
The Senior Regulatory Compliance Manager is responsible for providing independent quality assurance assessment of global regulatory compliance activities supporting clinical development programs, labelling compliance for investigational products (IP) assets within the Innovative Medicines portfolio.

This role serves as one of the Development Quality Assurance Leads ensuring investigational products, regulatory submissions, related quality systems, and vendor deliverables meet global regulatory requirements in the support of successful product development and registration. 

KEY RESPONSIBILITIES

• Lead independent quality reviews of regulatory labelling in global submissions strategies for all assigned Innovative Medicines Assets
• Partner closely with Global Regulatory Affairs, Clinical Development, Clinical Operations, Pharmacovigilance, Supply Chain, and external service providers to ensure compliance with applicable global regulations, GCP, GMP, GDP, and internal quality standards to promote a culture of quality, compliance, inspection readiness, and continuous improvement.
• Represent Development Quality Assurance on cross-functional labeling governance committees, forums and influence strategic quality decisions for global submission approval success
• Maintain expertise in GCP, GMP, GDP, ICH E6(R3), ICH Q9, and ICH Q10 regulatory expectations; lead quality risk assessments and provide strategic guidance for tactical and operational mitigation strategies aligned with ICH Q9 principles
• Provide quality oversight and compliance support during health authority interactions, inspections, and regulatory activities.
• Participate in the review of INDs, CTAs, amendments, annual reports, investigator brochures, DSURs, IMPD, marketing applications, and health authority responses, as assigned
• Perform independent ALCOA+ checks of global submissions and labelling documentation
• Review and approve change control, IP labels proofs, IMPD, and IP study manual, including assurance of all required translations, certificates, label proofs and in accordance to FDA, EMA, Health Canada, EU CTR, Annex 13, and other applicable local requirements
• Supports risk-based vendor/supplier qualification, maintenance of Quality Technical Agreements (QTA), and governance activities; including assignment of SCARS and performing for-cause audits and on-site monitoring of supplier/packaging activities
• Assess the impact of emerging global regulations on the Quality Management System (QMS) systems
• Author, review, and/or approve revised or new SOPs, work instructions, forms, and templates; leads training on new SOPs and requirements, as assigned
• Supports inspection readiness initiatives and support health authority inspections
• Drive continuous improvement through quality metrics, KPI trending, and supporting management review.

QUALIFICATIONS

Education:

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or Nursing, or related scientific discipline; advanced degree preferred

Experience:

• A minimum of 10 years of experience in Development Quality Assurance, Quality Systems, Regulatory Compliance, Clinical Quality, or related GxP-regulated pharmaceutical functions
• Experience supporting global innovative medicines product development programs and regulatory submissions for innovative medicines

Travel: 

• 15-25% domestic and international travel
  
  

  The presently-anticipated base compensation pay range for this position is $137,000 to $167,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

   

  The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.