Regulatory Affairs Associates , Mumbai

Roles and Responsibilities

• Compile and review Regulatory submission documents required in line with the relevant guidelines.
• Coordinate with relevant depts and prepare submissions.
• Review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
• Draft and review Product Information & labeling as required.
• Prepare version-controlled CMC writeup for the respective section.
• Perform registration compliance reviews against quality documentation.
• Preparation, submission and follow up of fresh / renewal of license with the State Licensing Authority and Central Licensing Authority.
• Preparation, submission, and follow-up of additional product permission from of license with State Licensing Authority and Central Licensing Authority.

Desired Candidate Profile

1) RA experience of 6-10 years

2) Initial experience in Analytical RnD will be an added advantage.

3) Should be well versed with country specific requirements (at least for the countries mentioned by the candidate in his/her resume)

4) Should be well versed with ICH guidelines.

5) Should have experience in reviewing technical documents of the dossier.

6) Should be open to learn.