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Regulatory Affairs Specialist (RAD-US Market,CMC, M3)

Regulatory Affairs Specialist (RAD-US Market,CMC, M3)

Creeno Solutions

6 - 11 years

|

10 - 18 Lacs

Posted:1 week ago| Platform:

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Skills Required

regulatory affairs fda pre approval pas m2 m3 bmr cbe module 2 module 3 pepfar nda post approval cbe-30 ra-us market anda cmc

Work Mode

Work from Office

Job Type

Full Time

Job Description

Position:

Qualification:

Experience:

Job Location:

Job Type:

Responsibilities:

Hands on experience with RA-US market

Planning, reviewing and submission for assigned ANDA and NDA projects within timelines. Adherence to high quality, and regulatory standards in dossiers.
Good interpretation of FDA queries. Meeting agreed upon timelines. Excellent drafting skill. Ensure adherence to high safety, 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).
Review and authorizing regulatory change controls. Module 2 and 3.
Review of BMRs, knowledge in specification clearance (for drug product, drug substance, and excipients etc.,), stability protocols,
Knowledge on product correspondence, controlled correspondence, and general correspondence etc.,

CMC Post Approvals:

Adherence to high quality and regulatory standards in submission of all post approval changes for assigned ANDAs and NDAs within timelines.
Preparation of Annual Reports/Updates (for ANDAs/NDAs, PEPFAR applications).
Preparation of the responses to the query received for post approval submission.
Knowledge on FDA guidance with respect to post approval changes and submission post approval changes like CBE, CBE-30, and Prior Approval Supplement (PAS) etc.,.
Review of BMRs, knowledge in specification clearance (for drug product, drug substance, and excipients etc.,), stability protocols,
Knowledge on preparation of Module 2 and 3 sections as per the post approval changes.

karthik.b@creenosolutions.com

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