Glenmark PharmaceuticalsRecruitment August 2020. Glenmark Pharmaceuticals is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer; he named the company after his two sons. The company initially sold its products in India, Russia, and Africa.
Important Vacancy details:
- Post Name: Senior Manager – Regulatory
- Education :B.sc,B.pharma,M.sc,M.pharma
- Experienced:11 to 15 years
- Location: Mumbai
- Salary : 18,00,000 – 20,00,000 P.A.
- Openings :01
- Email id: [email protected]
Note:Candidates who are unable to attend the interview can share their resumes to Above mail id.
Job Description: We have requirement for the post of Senior Manager – Regulatory in Glenmark Pharmaceuticals !
- Strategically evaluate all change proposals (site transfer/alternate process API/alternate API vendors/excipients/container closure vendor/pre-launch changes or any other change to approved dossier) received from various stakeholders and provide guidance in terms of filing strategy.
- Planning, and ensuring timely submission of various supplements by providing guidance to team for submission of various supplement i.e. PAS, CBE-30 and CBE-0 and other general correspondence.
- Technical evaluation of the deficiency received from FDA and coordination with various responsible stakeholders to ensure quick turnaround time for replying to Complete response letters/Information requests received on supplements from USFDA. Also evaluation of response received from R&D/Plant to ensure that the responses submitted are technically responded to meet FDA’s requirements and in turn result in faster approval of proposed change.
- Monitoring of timely submission of Annual Reports (AR) to the agency within two months of anniversary date and also ensure that it meets internal timelines as captured in the AR database.
- Provide support to ensure patient/pharmacist queries received from the Pharmacovigilance team are responded in a timely manner.
- Ensure regulatory compliance at all levels of operations. Coordination for USP forum monograph submission.
- Provide support to devise best strategies for various cost benefit programmes (alternate process/alternate API/excipient/container closure vendor/site transfer/any other changes to approved dossiers) run across the organization for US market
- Maintenance of various regulatory database to capture the complete history of the product.
- Keep updated with various guidelines from Health authorities
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online