Apnar Pharma Job Vacancy For Regulatory Affairs Department.

Apnar Pharma Job Vacancy For Regulatory Affairs Department.

Apnar Pharma Job Vacancy For Regulatory Affairs Department.

Dear Sir/Madam,

Greetings from the Apnar Pharma !!!

We have requirement in Regulatory Affairs Department.

Designation Level: Officer/Executive

Experience Required: 2 to 5 years

Education: B. Pharm / M. Pharm.

Job Location: Vadodara, Gujarat

Job Description

1. For CMC reviewer and compilation -Compilation and submission of eCTD dossier for new product application (ANDA/EU-MA)/Post approval submission to the regulatory authority (specifically EU/US)

-Hand on experience in preparation of CTD section as per regulatory requirements of different region -Having experience in preparation of query response and PAS, CBE and annual report.

-Have ability to co-ordinate with cross functional team

-Having experience for Drug listing and annual updates -Having ability to review documents as per current regulatory guidelines.

2. For Labelling

- Have experience of compilation of Labelling section of US ANDA/ EU MA

-Preparation and review of artwork related to ANDA in line with innovator product

-Maintain product life cycle for Labelling requirement in line with RLD updates

-Submission of labelling SPL through software as per regulatory requirements

If you know the suitable candidates, Please inform them to forward their updated Resume on hr@apanarpharma.in

Thanks & Regards,

Bharti Makwana

Manager - HR Apnar Pharma Private Limited