About This Role
Supporting regulatory compliance, product registration, and documentation activities is the core of this specialist role. It suits a detail-oriented and organized candidate with strong research and analytical skills who can interpret regulatory requirements and ensure products and business operations comply with applicable laws and industry standards.
Responsibilities
- Research and interpret applicable laws, regulations, guidelines, and industry standards
- Prepare, review, and submit regulatory applications, product registrations, licenses, and supporting documents
- Ensure all regulatory documentation is accurate, complete, and submitted within established deadlines
- Maintain regulatory records, product files, certificates, and compliance databases
- Coordinate with internal departments, external consultants, and regulatory authorities regarding submission requirements and approval processes
- Monitor changes in regulatory requirements and assess their impact on products and business operations
- Support regulatory audits, inspections, compliance assessments, and corrective action activities
- Identify potential compliance risks and assist in developing appropriate mitigation measures
- Track application progress, manage approval timelines, and coordinate registration renewals
- Provide regulatory guidance to relevant teams and support the implementation of compliance procedures
- Prepare regulatory reports and maintain organized documentation for internal reviews and external assessments
- Stay informed about regulatory developments and industry best practices to support continuous improvement
Requirements
- Bachelor's degree or diploma in Regulatory Affairs, Pharmacy, Life Sciences, Chemistry, Biology, Business Administration, or a related field, depending on the industry
- Basic understanding of regulatory compliance, product registration, and documentation procedures
- Strong research, analytical, and problem-solving skills
- Proficiency in Microsoft Office and familiarity with document management systems
- Excellent written and verbal communication skills
- Strong attention to detail and ability to maintain accurate records
- Good organizational and time management skills, with the ability to manage multiple tasks and deadlines
- Ability to work independently and collaborate effectively with cross-functional teams
- Professional integrity and commitment to confidentiality and compliance standards
- Adaptability and willingness to learn new regulations, guidelines, and industry practices
Nice to have:
- Familiarity with regulatory submission systems or relevant industry certifications
