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Associate - Regulatory Affairs

Associate - Regulatory Affairs

Clinchoice

1 - 4 years

2 - 6 Lacs

chennai

Posted:3 hours ago| Platform:

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Skills Required

training trade usage project implementation regulatory compliance dri new product development management regulatory affairs raw material

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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Pharmaceutical Manufacturing

Horsham Pennsylvania

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Associate - Regulatory Affairs