Senior Manager, Regulatory Compliance
About The Position
The Senior Regulatory Compliance Manager provides independent quality assurance assessment of global regulatory compliance activities supporting clinical development programs and investigational product (IP) labelling compliance within the Innovative Medicines portfolio. The role serves as a Development Quality Assurance lead, ensuring investigational products, regulatory submissions, related quality systems, and vendor deliverables meet global regulatory requirements in support of product development and registration. The position partners with regulatory, clinical, pharmacovigilance, supply chain, and external service-provider teams; provides quality oversight for submissions, labelling, vendors, and health-authority interactions; and supports inspection readiness and continuous improvement. The role includes 15–25% domestic and international travel.
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, Nursing, or a related scientific discipline.
- At least 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.
- Ability to travel 15–25% domestically and internationally.
Nice To Haves
- Advanced degree preferred.
Responsibilities
- Lead independent quality reviews of regulatory labelling in global submission strategies for assigned Innovative Medicines assets.
- Partner with Global Regulatory Affairs, Clinical Development, Clinical Operations, Pharmacovigilance, Supply Chain, and external service providers to promote compliance with applicable regulations, GCP, GMP, GDP, and internal quality standards.
- Represent Development Quality Assurance on cross-functional labelling governance committees and forums, influencing strategic quality decisions for global submission approval success.
- Maintain expertise in GCP, GMP, GDP, ICH E6(R3), ICH Q9, and ICH Q10 expectations; lead quality risk assessments and provide guidance on mitigation strategies aligned with ICH Q9 principles.
- Provide quality oversight and compliance support during health-authority interactions, inspections, and regulatory activities.
- Participate in review of INDs, CTAs, amendments, annual reports, investigator brochures, DSURs, IMPDs, marketing applications, and health-authority responses, as assigned.
- Perform independent ALCOA+ checks of global submissions and labelling documentation.
- Review and approve change controls, IP label proofs, IMPDs, and IP study manuals, ensuring required translations, certificates, and label proofs comply with applicable requirements.
- Support risk-based vendor and supplier qualification, Quality Technical Agreement maintenance, and governance activities, including assigning SCARs and performing for-cause audits and on-site monitoring of supplier and packaging activities.
- Assess the impact of emerging global regulations on Quality Management System processes and systems.
- Author, review, and/or approve new or revised SOPs, work instructions, forms, and templates; lead training on new SOPs and requirements as assigned.
- Support inspection-readiness initiatives and health-authority inspections.
- Drive continuous improvement through quality metrics, KPI trending, and management review support.
Benefits
- Annual performance bonus plan
- Medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- 401(k) savings plan
- Flexible spending accounts
- Employee assistance program
- Vacation time
- Sick time
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What This Job Offers
Job Type
Full-time
Career Level
Senior
