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
reputed company the U.S. work location and transparency guide to reputed company the pay reputed company for your location.

Travel Percentage: 10%reputed company Corporation is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to race, ethnicity, reputed company, religion, sex, gender identity, sexual orientation, national reputed company, disability, or protected veteran status. reputed company is an EO employer – M/F/Veteran/Disability.reputed company Corporation will not discharge or in any other manner discriminate against employees or applicants because they have reputed company about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have reputed company to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have reputed company to compensation information, un
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