Regulatory Affairs Associate

Job Description

A Regulatory Affairs Associatesupports the development and execution of regulatory strategies to ensure products meet all necessary legal and safety requirements.They prepare and manage regulatory documentation, interact with regulatory agencies, and contribute to the overall compliance of products with relevant laws and guidelines.Regulatory Strategy Support:Assisting in the development and implementation of regulatory strategies for products, ensuring they align with legal and scientific requirements
• Documentation Management:Preparing, reviewing, and managing regulatory submissions and documentation, including those for clinical trials and product registrations.
  • Submission Management:Overseeing the submission process to regulatory agencies and tracking submissions to ensure timely approvals.Compliance Monitoring:Ensuring that products and processes comply with all relevant regulations and guidelines
    • Labeling and Packaging Review:Reviewing and approving product labeling, packaging, and advertising materials to ensure compliance.Technical SkillsProject ManagementCommunication SkillsInterpersonal Skills
    Adaptability

Keyskills :
technicalmanagementcommunicationadaptabilityskillsinterpersonal