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Gurgaon, HR
Job Code:
  • Biotechnology & Science
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Job Details

Manage all aspects of the regulatory process for US and Canada submissions, viz, review and submission of the marketing authorization application, timely and satisfactory response to the deficiency lettersTo prepare and co-ordinate the submission of supplements, drug listing, renewals, etc.Manage a team that consists of several regulatory affairs personnel Participate in product teams with regard to implementation of regulatory requirements.Provide the Project teams with regulatory input in order to obtain timely regulatory approvals for the products as part of the product development planning.Provide regulatory expertise to analytical and formulation development teams and ensure that information is interpreted correctly.Review of the technology transfer documents with regards to US and Canada specific requirements.Handling of change controls.Maintain a working knowledge of regulatory requirements and guidelines and communicating changes in regulatory information to the team members.Update licensing and collect information on registration instructions and regulations.Maintain database of FDA-approved and marketing approved drugs.Flexibility to work for other regions, based on internal requirements, if required.TECHNICAL EXPERIENCEMust have thorough understanding of USFDA and Health Canada regulations and pertinent state and federal laws governing pharmaceutical products.Careful delegation of tasks whilst maintaining responsibility for final result.Careful planning to achieve accurate and timely results.Ability to discuss strategic and sensitive issues.Recognise recurring issues and analyse their causes in order to reach a solution.PERSONAL ATTRIBUTESGood communication skills.Be proactive in taking responsibilitiesHave good planning and organizing capabilitiesHave good inter-personal relationships
Degree: M.Pharm. (Pharmacy)

Additional Degree: B.Pharm. (Pharmacy)

Experience: 5-10


Analytical Chemistry | Goods Manufacturing Practices (GMP) | Quality Assurance/ Control
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