Friday, March 20, 2020

We are having the requirement for Regulatory Affairs department for our API Unit based at Chandigarh

We are having the requirement for Regulatory Affairs  department for our API Unit based at
Chandigarh


Department : Regulatory Affairs
Position : Asstt Manager or Deputy Manager or Manager
Location :  Chandigarh
Exposure to Regulated markets : European  Union or US
Relevant Experience : 7-15 Years
Educational Qualification : B Sc/B Pharma or MSc/M Pharma

JOB PROFILE :

 Drug Master Files for regulated markets (US, EU)

Regulatory queries/deficiencies received from authorities and customers.

Review of technical data required for DMF submissions Organization of fees of submission and review of raw data (specifications, analytical procedures, CoAs, stability data, BMRs, analytical method validation reports, SOPs,

Maintenance of deficiency database marketwise.

Review of technical data required for DMF submissions Organization of fees of submission and review of raw data.


Candidate must have experience in API  . Also have exposure in US , Europe Market  Interested candidates can share their cv at hr@neclife.com


With regards
Daljeet kour

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