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Regulatory Affairs (Labeling) For leading Pharma Compnay in Mumbai

8.00 to 10.00 Years   Mumbai City   23 Dec, 2020
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

Roles and ResponsibilitiesJob Title: Regulatory Affairs (Labeling) Company: Leading Pharma company in Mumbai Location Designation: Team Leader No. of Positions: 1 Division: FormulationDepartment: Regulatory Affairs Location: Mumbai Location Qualification: B.Pharma/ M.Pharma Years of Experience: 8 to 10 Years Salary Range: 15 LPAContact person: Mr.Zabi Moghal Mobile: 7676936384 Email: zabi@bvrpc.com

  1. Development and approval of Artworks including required change management activities
  2. Timely submission of labeling (artworks) with high level of quality and accuracy for new submissions, amendments and supplements.
  3. Co-ordinate with cross functional and global teams for ensuring the timely availability and release of approved artworks to meet the commercial requirements.
  4. Planning and maintenance of labelling tracker to ensure the availability of approved artworks as per timeline.
  5. Complies with all standards, procedures and policies for regulatory labelling submissions set forth for the Regulatory Function
  6. Remains knowledgeable about current regulations and guidance of regulatory labelling to perform day to day regulatory labelling activities.
  7. Responsible for ensuring compliance to Company s submission standards, policies and procedures.
Salary: Not Disclosed by RecruiterIndustry: Pharma / Biotech / Clinical Research Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology Role Category: Drug Regulatory Affairs/DocumentationRole: Regulatory Affairs ManagerEmployment Type: Full Time, Permanent , Education:UG -B.Sc - Any Specialization, B.Pharma - PharmacyPG - M.Pharma - Pharmacy, MS/M.Sc(Science) - Any SpecializationDoctorate - Doctorate Not Required

Keyskills :
global teamsclinical researchchange managementregulatory affairssetpharmasalaryresearchclinicalmanagementhealthcarecommercialcomplianceregulatorymaintenanceregulationsavailabilitybiotechnologymedicalGlobal CrossFunctional Team Leadershi

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