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Thursday, July 8, 2010

Executive Regulatory Affairs & Compliance

Executive Regulatory Affairs & Compliance

DesignationExecutive Regulatory Affairs & Compliance
Job Description•Timely filing of complete, high quality submissions, prompt, complete and accurate responses to RFIs and effective communication of approvals

a) Varying licences in markets that allow for this procedure

b) Preparing and filing renewal applications as per renewal schedule in concerned markets.

c) Checking and reviewing product artwork for country specific regulatory compliance.

d) Updating and being accountable for all the status logs maintained by the Unit for allocated molecules.

e) Implementing and Complying with the SOPs in effect.

•100% accurate and complete recording of all regulatory submissions, correspondence with authorities and approvals and any associated logs.

•All Helpdesk queries are answered in accordance with SLAs.
Desired Profile-A minimum of 1 years experience in regulated markets

-2 years experience in regulatory affairs.

-Experience in technical aspects of pharmaceutical product manufacture

-Knowledge of European Regulations, Guidelines and Application Procedures
Experience1 - 3 Years
Industry TypePharma/ Biotech/Clinical Research
RoleRegulatory Affairs Mgr
Functional AreaHealthcare, Medical, R&D
EducationUG - B.Pharma - Pharmacy
PG - Any PG Course - Any Specialization,Post Graduation Not Required
KeywordsEuropean Regulations,SmPCs,PILs
ContactSneha / Rashmi
Goldshield Services Pvt Ltd


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