Sun Pharmaceutical Industries Limited – Baroda invites applications for openings in Drug Regulatory Affairs – (Market: Asia, Brazil, and LATAM)
Sun Pharmaceutical Industries Ltd. is an Indian multinational pharmaceutical company headquartered in Mumbai, India. The company specializes in the development and manufacturing of generic and branded pharmaceuticals, as well as active pharmaceutical ingredients (APIs) and formulations.
Grade: Sr Executive / Manager
Qualification: M Pharmacy
Location: Baroda
Brief Job Description :
Regulatory submission of new products, variations, response to queries, Life cycle management for Asea, Brazil including other LATAM countries through the preparation of quality dossiers enabling timely approvals.
Area Of Responsibility:
1. New submissions:
a. Review & prepare CMC (Chemistry, Manufacturing, and Controls) dossiers for fresh submissions.
b. Review documents (Development report, scale-up report, specification, stability protocol), artworks, etc.
before initiation of Exhibit batches for adequacy.
2. Approval :
Review & prepare responses to deficiencies enabling approval of products filed to the regulatory agencies.
3. Lifecycle management for drug formulations:
a. Prepare and review variations as per the country requirements to support approval of changes such as API
vendor changes/changes in ROS/test parameters; DF site changes; harmonization of products etc.
b. Prepare and review re-registration/PCH dossiers & submit the same to regional office/ regulatory agencies
4. Regulatory compliance:
a. Prepare, Review, and circulate the approval package to stakeholders upon receipt of approval and update the
same based on queries and variations.
b. Ensure reposition of comprehensive product information into a central repository
C. Review regulatory filing impact of variations, change controls, etc.
APPLICATION PROCESS; Send your resume to: Rosemary.varghese@sunpharma.com. Freshers need not apply
Sun pharma regulatory affairs Job openings – Baroda