Manager-Regulatory & Business Continuity - US Market Sun Pharma

  • company name Sun Pharma
  • working location Office Location
  • job type Full Time

Experience: 5 - 5 years required

Pay:

Salary Information not included

Type: Full Time

Location: Haryana

Skills: change control, Regulatory submission, CMC dossiers, Review documents, Lifecycle Management, eCTD compilation

About Sun Pharma

Job Description

Job Summary Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals. Area Of Responsibility New submissions: Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. Review documents (Development report, scale up report, specification, stability protocol, analytical validation), etc. Before initiation of Exhibit batches for adequacy. Approval : Review & prepare response to deficiency enabling approval of products filed to regulatory agency. Lifecycle management for drug formulations: Prepare and review variation , Annual notification and labelling approval for US and OAM Review of change control and file variation as per country requirement Regulatory compliance: eCTD compilation Ensure reposition of comprehensive product information into central repository Review regulatory filing impact of variations, change controls, etc.,