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. We operate primarily under a business to business (B2B) model and have an excellent track record in the development, manufacturing and marketing of complex injectables.
Gland Pharma We have vacancies in Regulatory Affairs for Hiring Officer / Executive / Sr. Executive / Sr. Manager- Regulatory Affairs- API at Gland Pharma Ltd; Leading Injectables manufacturing Company for Global Market.
JOB DESCRIPTION:
- Department: Drug Regulatory Affairs.
- Market: India.
- Location: Hyderabad.
- Positions: Executive/Sr. Executive.
- Salary: As per the company norms.
Roles and Responsibilities:
- Preparation & submission of Application to obtain certificates under EU written confirmation certification scheme and WHO GMP certification scheme.
- Preparation & submission of Application to obtain – Manufacturing license, Loan license, Wholesale license and test license.
- 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.
- 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.
- Preparation & submission of Application to obtain Import Licence, Test license (Import) and No Objection Certificates (NOC) for manufacture of unapproved drugs.
- Handling of queries/deficiencies raised by State & Central Drugs Control Authorities (DCA & CDSCO).
- 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.
- Review of artworks for drug products meant for India.
- Assisting in DCA &/ CDSCO Regulatory Audits.
Candidates must have experience in API- licensing/certification’s
Interested with relevant candidates can drop CV afroz.bari@glandpharma.com
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We are hiring- Regulatory Affairs (Injectables) Sr. Manger-US market. We have vacancies in Regulatory Affairs for Sr. Manager at Gland Pharma Ltd; Leading Injectables manufacturing Company for Global Market.
- Designation : Sr. Manager – Regulatory Affairs
- Experience : 11 to 15 years of experience Regulatory Affairs from INJECTABLES in US Market background from reputed pharma company
- Location : Hyderabad
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.
If interested please forward your resume to afroz.bari@glandpharma.com mentioning your current CTC, Expected CTC and notice period.
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