Senior Executive

Preparation of DMF / ASMF / CEP dossiers as per the ICH M4 CTD / eCTD guidelines.

Preparation of response to queries raised by various regulatory agencies customer.

Preparation of Applicant s Part of ASMF as per customer requirement and restricted part of ASMF as per regulatory requirement.

Initiation of activity for timely notification / prior approval from regulatory agencies in case of any changes required to the existing DMF / ASMF / CEP on ongoing basis

Initiation preparation of renewals or revisions for CEPs / annual reports for USDMFs / ASMF variations.

Keeping update about the current global regulatory requirement

Evaluation of change control applications for regulatory implications.

• Reviewing analytical method validation reports, stability protocols, concerned standard operating procedures and adding regulatory input to make it in line with regulatory authorities

Skills Required

Senior Executive, analytical method validation , Ich