Regulatory Affairs Associate

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. Skills: Legal Knowledge Strong Writing and Documentation Decision-making Time Management Situational Analysis Preferred qualification: Bachelors degree (or equivalent) in a relevant discipline 2-3 year of experience