Regulatory Affairs Consultant

We are seeking a dedicated and experienced Regulatory Affairs Consultant to join our team full-time. As a Regulatory Affairs Consultant, you will be instrumental in ensuring our company complies with all applicable regulations and standards within our industry. You will play a key role in developing regulatory strategies, preparing submissions, and maintaining compliance throughout the product lifecycle. Your expertise will be crucial in navigating regulatory complexities, liaising with regulatory authorities, and providing guidance to internal teams.

Roles And Responsibilities

• Regulatory Strategy Development: Develop and execute regulatory strategies aligned with business objectives to ensure compliance with local, national, and international regulations.
• Regulatory Submissions: Prepare, review, and submit regulatory filings and applications such as product registrations, notifications, and licenses to regulatory authorities.
• Compliance Monitoring: Monitor changes in regulatory requirements and assess their impact on products and operations. Provide timely advice and updates to internal stakeholders.
• Quality Assurance Support: Collaborate closely with Quality Assurance teams to ensure regulatory requirements are integrated into quality processes and procedures.
• Cross-functional Collaboration: Work closely with R&D, Legal, Marketing, and Operations teams to integrate regulatory considerations into product development and commercialization processes.
• Regulatory Intelligence: Stay informed about regulatory developments, trends, and best practices through research and networking within the industry.
• Audits and Inspections: Support regulatory audits and inspections, including preparation, response, and implementation of corrective actions.
• Training and Education: Provide training to internal teams on regulatory requirements, policies, and procedures to ensure compliance awareness across the organization.
• Risk Assessment and Management: Conduct risk assessments related to regulatory compliance issues and develop strategies to mitigate risks effectively.
• Documentation and Record-keeping: Maintain accurate regulatory documentation, records, and databases in compliance with regulatory standards and internal policies.
  
  

Compensation

• Competitive salary based on experience and qualifications.
• Comprehensive benefits package including health insurance, retirement plan, paid time off, and professional development opportunities.