We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

Noida/Mumbai- India

Senior Established Product Manager


Your Job

•        Responsible for maintenance of the lifecycle of the assigned products  
•        Variations: Preparing post-approval change submission packages
•        Renewals: Preparing global renewal application package for local submission, alignment of the  supporting documents for renewal application submission with country affiliates
•       Safety reports (PBRER/PSUR contributions, PSUSAs)
•       Support license withdrawals
•        Regulatory support for NDAs or out-licensing
•        Response to deficiency letters/country requests: handling of HA queries with Alignment of regulatory strategy and preparation of response packages
•        Assessment and approval of Local labelling strategy
•        Launch/deletion application assessments
•        Processing of administrative documents
•        Other LCM activities, as may be required as part of the Established product manager activities

Your Profile

• Experience required minimum 8years
• Good exposure in Europe market
• Previous experience in Regulatory Affairs labelling 

If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.




 

Agencies only by prior agreement for the specific job opportunity.