Regulatory Affairs

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.

Responsibilities

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

#J-18808-Ljbffr