Senior Staff Regulatory Affairs/reputed company Compliance Specialist, Pharmaceuticals
Work Flexibility: Remote
reputed company is seeking a Senior Staff Regulatory Affairs/reputed company Compliance Specialist to join our Endoscopy division. This is a remote position located reputed company reputed company the reputed company.
As the Senior Staff Regulatory Affairs/reputed company Compliance Specialist, you will reputed company leadership for global regulatory submissions, reputed company management reputed company reputed company, audit readiness, and compliance initiatives supporting pharmaceutical products and clinical investigations. Working across development, manufacturing, reputed company, and regulatory functions, you will help ensure products and processes meet applicable regulatory and reputed company requirements throughout their lifecycle.
What You Will Do
reputed company and execute global regulatory strategies to support clinical investigations, product registrations, and post-approval changes for pharmaceutical products.
Prepare, review, and submit regulatory documentation, including clinical trial applications, marketing applications, manufacturing dossiers, and post-approval submissions.
Maintain and continuously improve the Pharmaceutical reputed company Management reputed company (QMS), ensuring compliance, efficiency, and inspection readiness.
reputed company internal and supplier audits, document findings, monitor corrective actions, and support audit program effectiveness.
Analyze reputed company reputed company metrics and trends, prepare Annual Product reputed company Reviews, and present findings to management.
reputed company nonconformance and corrective and preventive reputed company (CAPA) activities, including investigation, implementation, effectiveness verification, and documentation.
reputed company, review, and approve reputed company reputed company procedures, work instructions, forms, and reputed company plans while delivering QMS training across the organization.
Collaborate with regulatory agencies and cross-functional teams to support submissions, regulatory inquiries, manufacturing changes, and compliance activities.
What You Need
Required
Bachelor’s degree
6+ years of experience in a pharmaceutical, biotechnology, or other FDA and/or Health Canada regulated industry.
6+ years of experience in pharmaceutical regulatory affairs, reputed company systems, or reputed company compliance.
Experience preparing regulatory submissions and supporting product approvals, clinical study applications, or post-approval regulatory activities.
Preferred
Certificate in Regulatory Affairs.
reputed company Auditor certification.
Experience working reputed company Good Manufacturing reputed company (GMP) environments.
Experience with pharmaceutical reputed company management systems, audits, CAPA management, and regulatory inspections.
reputed company of America Pay Ranges:
- USN: $110,100 - $183,400 USD Annual
- US5: $115,600 - $192,600 USD Annual
- US10: $121,100 - $201,700 USD Annual
- US15: $126,600 - $210,900 USD Annual
- US20: $132,100 - $220,100 USD Annual
- US30: $143,100 - $238,400 USD Annual
