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Dgm/gm - Regulatory Affairs - API

Manesar, Haryana

Mankind Pharma

Job Description

Position will be responsible for
Preparation, review and submission of Drug Master Files in eCTD format for the regions US, EU and Health Canada through ESG and CESP and experience in ROW markets.
Preparation and submission of self-identification, addition of importers and NDC labels to USFDA.
Life cycle management of the Drug Master Files (Amendments, Annual Reports, CEP updates and Bi-Annual updates).
Preparation, review and submission of Applicant's Part DMF (Open Part DMF) and Technical data package to customers.
Handling of DMF deficiencies received from regulatory agencies with coordination of the cross functional teams within the stipulated time.
Handling of customer queries related to DMF / Product.
Preparation, review and submission of Letter of authorization / Letter of access (LoA) to regulatory authorities & customers.
Review and approval of changes for the DMF filed products w.r.t regulatory point of view.
Experience in Japan accreditation by providing required documents to the PMDA through agent.
Supporting the regulatory / customer audits.
Knowledge on eCTD guide lines and update with the current guide lines.

Company Description

Mankind Pharma, the 8th largest Pharmaceutical Company of India, was incepted in 1995 with a... meagre capital of 50 lakhs and 20 employees. Today, we are amongst the top 5 fastest growing Pharmaceutical companies of India with an employee base of more than 10000 and heading towards a turnover of INR 3000 crores. We aspire to aid the community in leading a healthy life through two parallel objectives: formulating, developing & commercializing medicines and delivering affordable & accessible medication that satisfies urgent medical needs.  Read full description

Additional Information

Last updated:
Job type:
Full time
Position type:
Minimum experience:
More than ten years
Compulsory Education
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