Regulatory Affairs Executive (Australia Market)

Novumgen Limited; Vadodara; On-site; INR 6,065,000 - 8,760,000; Full time

Job summary

Novumgen Limited is seeking a Regulatory Affairs specialist for the Australia market. You will support preparation and submission of regulatory applications, variations, amendments, and other submissions to the TGA.

The role involves compiling and reviewing regulatory documentation, providing cross-functional regulatory support, handling TGA queries, maintaining project trackers, and supporting post-approval lifecycle activities.

Qualifications

• 2 to 7 years of experience required for the Australia market.

Responsibilities

• Support preparation and submission of regulatory applications, variations, amendments, and other applicable submissions to TGA.
• Compile and review regulatory documentation to ensure submission content is complete, accurate, and consistent.
• Provide regulatory support to cross-functional teams.
• Handle TGA queries and deficiency responses for regulatory submissions.
• Communicate with partners for timely availability of required information and documents.
• Ensure timely submission of variations and other regulatory requests to the relevant regulatory authority.
• Maintain regulatory project trackers.
• Support post-approval regulatory maintenance and lifecycle activities.

Job description

Role & responsibilities (Australia Market)

• Support preparation and submission of regulatory applications, variations, amendments, and other applicable submissions to TGA.
• Compile and review regulatory documentation to ensure submission content is complete, accurate, and consistent.
• Provide regulatory support to cross-functional teams.
• Handle TGA queries and deficiency responses for regulatory submissions.
• Communicate with partners for timely availability of required information and documents.
• Ensure timely submission of variations and other regulatory requests to the relevant regulatory authority.
• Maintain regulatory project trackers.
• Support post-approval regulatory maintenance and lifecycle activities.

Preferred candidate profile

• 2 to 7 Years of Experience required for the Australia Market.