Regulatory Affairs

Full Job Description

Premium Solutions Consultancy is seeking a highly skilled and motivated Regulatory Affairs professional to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our client projects. You will work closely with cross-functional teams to prepare and submit regulatory applications, maintain product registrations, and monitor regulatory changes.

• Prepare and submit regulatory applications, including product registrations and notifications
• Coordinate with internal and external stakeholders to collect necessary documentation and information
• Maintain up-to-date knowledge of relevant regulations and guidelines
• Monitor and communicate changes in regulatory requirements that may impact our clients
• Conduct regulatory assessments for new products and ensure compliance throughout the product lifecycle
• Participate in regulatory agency inspections and audits
• Collaborate with cross-functional teams to develop regulatory strategies and plans
• Review and provide input on labeling and promotional materials to ensure compliance

Requirements

• Bachelor's degree in a scientific or healthcare-related field
• Minimum of 3 years of experience in regulatory affairs in the pharmaceutical, medical device, or biotechnology industry
• Strong knowledge of local and international regulatory requirements and guidelines
• Excellent communication and project management skills
• Experience in preparing and submitting regulatory applications
• Attention to detail and strong analytical skills
• Ability to work independently and in a team environment