Associate - Regulatory Affairs

2 days ago


Chennai, Tamil Nadu, India ClinChoice Full time ₹ 2,00,000 - ₹ 6,00,000 per year

Job Title: Associate – Regulatory Affairs 
Employment Type: Contract (Duration: 1 year)
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.



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