Regulatory Affairs Specialist

Job Description

We are looking for a highly organized Regulatory Affairs Specialist to join our compliance team. The ideal candidate will have exceptional attention to detail and strong documentation skills, ensuring adherence to industry regulations and standards.

Responsibilities

• Develop and maintain documentation control processes and procedures.
• Ensure compliance with regulatory standards and requirements.
• Review and update documentation to meet evolving quality standards.
• Manage the document change control process effectively.
• Collaborate with various departments to produce high-quality documentation.
• Conduct document audits to ensure accuracy and compliance.
• Provide training on documentation control processes to staff.
• Support audits and inspections related to documentation.
• Identify opportunities for process improvement within the documentation control system.

Requirements

Education

• Bachelor's degree in a relevant field
• Master's degree in Quality Assurance or a related field is preferred

Experience

• 3+ years of experience in the pharmaceutical industry

Technical Skills

• Regulatory Compliance
• Quality Assurance Processes

Soft Skills

• Analytical Skills
• Problem-Solving Skills

Certifications

• Certified Quality Auditor (CQA)
• Regulatory Affairs Certification (RAC)

Languages

• English: Fluent

Advantageous

• Knowledge of GMP (Good Manufacturing Practices): Understanding of GMP guidelines to ensure compliance in documentation.
• Certifications in Six Sigma or Lean methodologies: Proficiency in quality improvement methodologies will be considered an advantage.

Benefits

• Comprehensive health benefits package
• 401(k) plan with attractive matching contributions
• Work-from-home options available
• Employee wellness initiatives
• Tuition reimbursement for continuing education

Company Culture

• Diversity and Inclusion: We value diverse perspectives and strive to create a welcoming environment for all.
• Empowerment: We empower our employees to take initiative and make impactful contributions.
• Innovation: Encouraging a growth mindset and innovative thinking is at the heart of our company culture.