Sun Pharmaceutical Released Job Openings On 27-11-2021. Sun Pharma beginnings in 1983, Sun Pharma has grown to become the 5th largest generic pharmaceutical company in the world and No. 1 in India. Application form link provided at the end of post.
Sun Pharmaceutical Recruiting M.Pharm Candidates with 8 to 10 Years experience in any of these US Markets is a must for Manager Regulatory Affairs position.Complete Details for the Manager Regulatory Affairs as follows.
Important Details :
- Location: Delhi, India Hybrid
- No of Vacancies:NA
- Details of Salary: NA
- Opening date for online Application:27-11-2021
- Mode of application :Online
- How To Apply:At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
Regulatory submission of new products, variations, response to queries, Life cycle management for Sun Sahara Africa markets through preparation of quality dossiers enabling timely approvals.
Area Of Responsibility
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 response to deficiency enabling approval of products filed to regulatory agency.
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 approval package to stake holders upon receipt of approval and update the same based on queries and variations.
b. Ensure reposition of comprehensive product information into central repository
C. Review regulatory filing impact of variations, change controls, etc.