Glenmark Vacancies | Glenmark LTD Published Notification For Officer/ Sr. Officer – Regulatory Affiars Post
Company Details :
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.
Post Detail :
- 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
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- 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