Regulatory affairs Officer

2 weeks ago


Gurgaon, Haryana, India Lifelancer Full time

Job Title: Regulatory affairs Officer

Job Location: Gurugram, Haryana, India

Job Location Type: On-site

Job Contract Type: Full-time

Job Seniority Level: Executive

Skills:
DMF, ICH, DRUG MASTER FILE, API, Preparation of LOA, Use of eCTD software's,

Preparation and compilation of DMF for US, EU, CEP, Canada, Japan, China, Brazil and other semi-regulated markets.

Submission of technical data package and Applicants Part for semi-regulated markets

Submission of response to deficiencies received from authorities and customers

Periodic DMF updates (annual report for USDMFs and CEP renewal) and DMF amendments for post approval changes for US, EU, Canada, CEP and other markets

Use of eCTD softwares and submission gateways like ESG & CESP

Providing regulatory inputs in early development phase of APIs

Review of change controls and technical data required for DMF submissions

Collection and review of data (AMV, process Validation stability etc.) required for compilation DMF

Preparation of LOA and commitment and data management

Submission of change notification for customer.

Tracking of changes in pharmacopoeia, regulatory guidance, current trends / regulatory expectations and identification of gaps

Maintenance of database for regulatory submissions including customer notifications

Well versed with current regulatory guidelines.

Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

For more details and to find similar roles, please check out the below Lifelancer link.

https://lifelancer.com/jobs/view/10e5a9a46e7379aab0ac75653c9ce24c

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