Regulatory Affairs Executive

B&S Group; Vadodara; On-site; INR 700,000 - 1,100,000; Full time

Job summary

B&S Group in Vadodara, India, is seeking a Regulatory Affairs professional to support dossier preparation for variations in UK/EU markets. The role involves compiling product information documents and coordinating with cross-functional teams to enable regulatory submissions.

You will contribute to regulatory strategy, provide inputs for development programs, and assist in renewal filings for lifecycle management. It is a hands-on position requiring attention to detail and teamwork.

Responsibilities

• Prepare dossier sections and product info docs for variations in UK/EU markets.
• Prepare deficiency responses and National phase docs for variations in UK/EU submissions.
• Prepare renewal applications for product life cycle management.
• Provide inputs for regulatory strategy and contribute to development programs.
• Coordinate with CMC and cross-functional teams for smooth regulatory submissions.
• Execute regulatory functions as needed to support compilations.

Job description

1. Prepare dossier section and product information documents for variations in UK/EU Market.

2. Prepare deficiency responses and National phase documents for submission of variations in UK/EU Market

3. Prepare renewal application for product life cycle management.

4. To provide inputs for regulatory strategy and contributing to development programs.

5. Co-ordination with CMC team and other cross functional department for smooth regulatory submissions.

6. Carry out regulatory functions as and when required supporting the regulatory compilations.