Glenmark Pharmaceuticals Limited 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.
Officer/ Sr. Officer – Regulatory Affiars
Qualification: B.Pharm/ M.Pharm
Experience: 3 to 4 Years
Work Location: Head Office, Andheri
Profile Summary:
The objective of the role is to mainly
maintain regulatory Database for
Global Regulatory Registrations. The
person will be responsible for
ensuring 100% compliance to SOP.
To liaise with different stake holders of global markets for gathering of regulatory data. Provide technical review of data or documents that will be incorporated into regulatory database.
Responds to queries to
respective stake holders
Roles & Responsibilities
Maintain regulatory database. Actively contribute for data collection, data entry and peer review
Generate reports as per requirements, respond to
queries from different stake holders.
To support internal and external audits.
Keep track of the
product submissions & approvals and variation submissions and approvals by getting the inputs
from different stakeholders
Co-ordinate with different internal and external stakeholders for the data required to maintain regulatory database.
Perform gap analysis at the
time of data or document receipt, ensure gaps are closed. Liaise with overseas offices of Glenmark
and other concermed departments to get documents/ data required for maintaning regulatory database.
Read various regulatory updates/guidance’s from health authorities and implement the same. To be
aware of regulatory database and technical requirements for maintaining database. To give the
training to new joiners and stakeholders on Adhoc basis
Skills:
Sufficient knowledge and
experience in maintenance of regulatory database for pharmaceutical products. Perform gap analysis. Good Communication skills to Liaise with different stake holders
Exposure of xEVMPD/IDMP
submission experience is preferable.
Kindly reach out at Simran.Gill@glenmarkpharma.com
