We are having the requirement for Regulatory Affairs department for our API Unit based at
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 firstname.lastname@example.org