Regulatory Affairs Specialist

No of Positions : 5

Experience Require: 3 to 8 yrs

Qualification: M Pharm

Job Location: Hyderabad

Description:

Planning, reviewing and submission for assigned ANDA and NDA projects.

Excellent drafting skills for FDA Deficiencies with high quality and regulatory standards in response.

Evaluation and good interpretation of post approval changes.

Submission of Supplements like CBE, CBE-30 and Prior Approval Supplement (PAS), Annual Reports.

Review and authorizing regulatory change controls.

Knowledge of eCTD, Module 2and 3.

Formulate US Regulatory filing strategy for new projects.