We are seeking an experienced and detail-oriented Regulatory Affairs Manager to oversee regulatory compliance and ensure that the company’s products, services, and operations comply with applicable laws, regulations, and industry standards. The successful candidate will manage regulatory submissions, maintain relationships with regulatory authorities, monitor changes in legislation, and provide strategic regulatory guidance to internal teams.
Key Responsibilities
- Develop and implement regulatory strategies aligned with business objectives.
- Ensure company products, services, and operations comply with applicable regulatory requirements.
- Prepare, review, and submit regulatory applications, registrations, licenses, and supporting documentation.
- Maintain accurate regulatory records, databases, and documentation.
- Monitor changes in laws, regulations, guidelines, and industry standards that may affect the business.
- Assess the potential impact of regulatory changes and recommend appropriate actions.
- Liaise with government agencies, regulatory authorities, and other external stakeholders.
- Coordinate regulatory inspections, audits, and compliance assessments.
- Respond to regulatory inquiries and ensure timely resolution of regulatory issues.
- Work closely with product development, quality assurance, legal, compliance, marketing, and operations teams.
- Review product labels, promotional materials, technical documentation, and other materials for regulatory compliance.
- Identify regulatory risks and develop strategies to mitigate them.
- Provide regulatory guidance and training to employees and management.
- Prepare regulatory reports and present compliance updates to senior management.
- Ensure timely renewal of permits, licenses, registrations, and certifications.
- Support the company in maintaining strong relationships with regulatory authorities.
- Develop and maintain regulatory policies, procedures, and standard operating practices.
- Conduct internal regulatory compliance reviews and recommend corrective actions.
Qualifications & Requirements
- A Master’s degree in Regulatory Affairs, Compliance, Business Administration, or a related discipline is an added advantage.
- 5–8 years of relevant experience in regulatory affairs, regulatory compliance, quality assurance, or a related field.
- Previous experience in a managerial or supervisory regulatory role is preferred.
- Strong knowledge of applicable regulatory frameworks, compliance requirements, and industry standards.
- Experience preparing and managing regulatory submissions and documentation.
- Strong understanding of regulatory risk management and compliance processes.
- Excellent analytical, organizational, and problem-solving skills.
- Strong written and verbal communication skills.
- Excellent stakeholder-management and negotiation abilities.
- High attention to detail and ability to manage multiple regulatory projects simultaneously.
- Proficiency in Microsoft Office and regulatory information-management systems.
Key Skills & Competencies
- Regulatory compliance
- Regulatory strategy
- Risk management
- Policy development
- Regulatory submissions
- Compliance monitoring
- Audit and inspection management
- Documentation management
- Stakeholder management
- Research and analysis
- Problem-solving
- Communication and negotiation
- Attention to detail
Key Performance Indicators (KPIs)
- Regulatory submission accuracy and timeliness
- Compliance rate
- Successful regulatory approvals and registrations
- Audit and inspection outcomes
- Regulatory issue resolution time
- License and certification renewal rate
- Number of regulatory non-compliance incidents
- Regulatory risk mitigation effectiveness
- Accuracy and completeness of regulatory documentation
