Regulatory Affairs Associate

0 - 3 years

2 - 5 Lacs

Posted:1 week ago| Platform: Naukri logo

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Work from Office

Job Type

Full Time

Job Description

Responsibilities:

1.Document Preparation:

a) Assist in preparing and reviewing regulatory submission documents (e.g., CDSCO).

b) Ensure accuracy and compliance with regulatory guidelines.

2.Filing and Submissions:

a) Help coordinate and submit documents to regulatory bodies.

b) Maintain detailed records of all regulatory submissions and approvals.

3.Compliance Support:

a) Monitor product compliance with current regulations and standards. b) Help ensure documentation aligns with regulatory changes and updates.

• Comprehensive understanding of products and technologies

• Review the unique products and search the regulatory data of particular product.

• Develop and write clear arguments and explanations for new product licenses and license renewals

• Provide the strategic advice to senior management throughout the development of new product

• Take part in the development of marketing concepts and approve packaging and advertising before a products release

• Monitor and set timelines for licence variations and renewal approvals. • Update/Report the everyday work to the Reporting Manager.

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