Gland Pharma Walk In Interview 2023.Gland Pharma Notification full details below..Interested and eligible candidates can attend interview on scheduled time and venue.Gland Pharma has grown over the years from a contract manufacturer of small volume liquid parenteral products, to become one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets.
- Department: Executive-AM: Regulatory Affairs/Officer/ Executive/Sr. Executive – Regulatory Affairs- API
- Qualification: Any Graduate/Any Postgraduate
- Experienced: 2-8 Years
Job Description: Greetings from Gland Pharma Ltd!
Important Details :
- Location: Hyderabad
- Post of date:08/07/2023
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face To Face Interview
- Interview Rounds of Interview: HR
Roles and Responsibilities
Please find the below Job description.
Responsible for compilation and submission of ANDAs, supplements (PAS, CBE-30 and CBE-0) and Annual Reports in eCTD/CTD to Regulatory Agencies
To address the deficiencies received from Various regulatory Agencies on time.
Drafting and reviewing of CMC sections for submission of Dossiers to Europe, Canada, Australia etc.
Responsible for submission of response to Complete Response Letter, DRL or IR from USFDA.
Review of BPCRs, Raw Material /Finished Product Specifications, STPs, CoAs, Analytical/Process Method Validations, PDRs, Annual Product Reviews, Stability protocols, Stability Data and other regulatory documents
Responsible for eCTD submission, publication and product life-cycle management.
Preparation of Controlled Correspondences to seek clarification from USFDA.
Interested with relevant candidate share CV to
Preferred candidate profile
Candidate must have injectable experience
Dept.: Drug Regulatory Affairs.
Positions: Executive/Sr. Executive.
1. Preparation & submission of Application to obtain certificates under EU written confirmation certification scheme and WHO GMP certification scheme.
2. Preparation & submission of Application to obtain – Manufacturing license, Loan license, Wholesale license and test license.
3. Preparation & submission of Application to obtain Certificates like – Good Manufacturing Practices (GMP) Certificate, Good Laboratory Practices (GLP) Certificate, Free Sale Certificate, COPP, Neutral Code Certificate and Technical staff approval under manufacturing licenses.
4. Preparation & submission of Application to obtain Certificates like – Performance Certificate, Manufacturing & Marketing Certificate, Standard Quality Certificate, Capacity & Quality Certificate, Market Standing Certificate, Non-Conviction Certificate, and Production Certificate.
5. Preparation & submission of Application to obtain Import Licence, Test license (Import) and No Objection Certificates (NOC) for manufacture of unapproved drugs.
6. Handling of queries/deficiencies raised by State & Central Drugs Control Authorities (DCA & CDSCO).
7. Submission of licence applications through electronic system i.e. SUGAM portal of CDSCO and ODLS portal of DCA, Telangana and SLS portal of DCA, A.P.
8. Review of artworks for drug products meant for India.
9. Assisting in DCA &/ CDSCO Regulatory Audits.
Desired Candidate Profile
Candidates must have experience in API- licensing/certification’s
Interested with relevant candidates can drop CV