Associate - Regulatory Affairs

Job Title: Associate – Regulatory Affairs 
Employment Type: Contract 
Location: Chennai
Experience: 0–6 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.