Associate - Regulatory Affairs at ClinChoice

Chennai, tamil nadu, India -

Full Time

Start Date

Immediate

Expiry Date

29 Jan, 26

Salary

0.0

Posted On

31 Oct, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Review, Compliance, Documentation, Formulations, Project Management, Cross-Functional Collaboration, Innovation Platforms, Raw Materials, Reporting, Training, Evaluation, Impact Assessment, Best Practices, Product Development, Portfolio Management, Regulatory Requirements

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

The Associate in Regulatory Affairs will work with local operating companies to ensure regulatory review and approval of formulations and raw materials. Responsibilities include evaluating compliance with local regulations and internal standards, preparing documentation, and managing project implementation plans.