Associate - Regulatory Affairs

3 weeks ago


Chennai India ClinChoice Full time

Job Description Job Title: Associate Regulatory Affairs Employment Type: Contract Location: Chennai Experience: 06 months Roles and Responsibilities: - Work with local operating companies to provide regulatory review and approval of formulations, raw materials, and their constituent information to ensure completeness, accuracy, and compliance. - Responsibilities include verification of: Trade name Manufacturer INCI name CAS/EINECS # Percentage of constituent Regional and global regulatory requirements - Evaluate the potential impact to regulatory compliance and/or reporting/documentation requirements; interact with the appropriate J&J personnel. - Evaluate formulations for innovation platforms, new product development, and marketed products to ensure compliance with local regulations and internal J&J standards. - Prepare and compile required documentation, working with cross-functional partners, as required. - Work with Client's PR&S DRI's to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks. - Use existing best practice documents for the raw material/RMQ review process. - Use existing best practice documents and work instructions for raw materials and formulations review and approval process. Deliverables: - Regulatory compliance evaluation of new raw materials, existing materials, and change-impacting materials in the portfolio, as well as reporting/documentation requirements. - Regulatory compliance evaluation of formulations for innovation platforms, new product development, and marketed products. - Provide weekly updates to Client's PR&S DRI's. - Provide training and education to Provider offshore resources. - Conduct portfolio survey.



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