Manager-Regulatory & Business Continuity - US Market SUN PHARMA

5.0 - 9.0 years

0 Lacs

haryana

On-site

You will be responsible for regulatory submission of new products, variations, response to queries, and life cycle management for the US and OAM regions. This will involve preparation of quality dossiers to ensure timely approvals. Key Responsibilities: - Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review documents such as Development report, scale up report, specification, stability protocol, analytical validation, etc., before initiation of Exhibit batches for adequacy. - Review & prepare responses to deficiencies to enable approval of products filed to regulatory agency. - Prepare and review variations, Annual notifications, and labelling...

Posted 17 hours ago

AI Match Score

Apply

Manager-Regulatory & Business Continuity - US Market SUN PHARMA

5.0 - 9.0 years

0 Lacs

haryana

On-site

As a Regulatory Submission Specialist, your role involves handling the regulatory submission of new products, variations, and responses to queries for the US and OAM regions. Your primary responsibility is to prepare quality dossiers to ensure timely approvals for life cycle management. Key Responsibilities: - Review and prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions. - Review various documents such as Development reports, scale-up reports, specifications, stability protocols, and analytical validations before initiating Exhibit batches. - Prepare responses to deficiencies to facilitate the approval of products filed with regulatory agencies. - Manage the ...

Posted 2 months ago

AI Match Score

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.