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Professional 2 For Regulatory Publishing

6.00 to 10.00 Years   Hyderabad   11 Feb, 2021
CSC India Pvt Ltd
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaSales / BD
EmploymentTypeFull-time

Job Description

Professional 2 Life Sciences BPSExperience: 7+ years of Regulatory PublishingJob Location: Hyderabad

  • Managing & motivating the team towards a common goal and keep them focused
  • Ensuring that service levels are met and strive to exceed service levels
  • Planning and managing training and ensure staff are adequately trained
  • Perform submission publishing, assembly and distribution activities.
  • Performing submission readiness checks.
  • Publishing documents for eCTD, NeeS, paper, and other PDF format submissions.
  • Performing final technical quality review and technical validation (eCTD)
  • Notifying relevant stakeholders that the file is ready for approval
  • Compiling SAS and other datasets and non-PDF files.
  • Dispatching submission to the relevant authority (eCTD, NeeS, paper) or affiliate so that affiliate can dispatch to authority;
  • Knowledge of FDA / ICH guidelines, Life Sciences & Pharmaceutical industry
  • Knowledge of health authority procedures/guidance regarding electronic submissions
  • Performing post-submission processing activities such as receiving acknowledgment from the authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders
  • Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata.
  • Monitoring and reporting submissions activity, such as reporting volume, timelines, and quality metrics; informing future planning and forecasting activities; supporting overall regulatory intelligence
  • Ensuring ongoing coaching of team members and ensure personal development plans are in place for all team members
  • By continually up-grading domain knowledge
  • Following company rules and standard operating procedures.
  • Adhering to all Security Policies and Procedures
  • Promoting a positive and professional image of the team always.
  • Need to abide to the existing Information Security Policies and Procedures
Others Imp:-Drug development process from beginning to end-Publishing pharmaceutical developments-Good clinical practice.Qualification:B.Pharmacy, M.Pharmacy, Bachelors in Life Sciences, Biotechnology, Pharm D. Interested can share their resume to gbr4@dxc.com keeping the same subject line as above:Updated CV -Current company - Total-experience - Relevant experience(Regulatory Publishing)- Highest qualification - Current CTC -Expected CTC - Notice period Current Location:Ph#Regards,Gopala BRTalent AcquisitionSalary: Not Disclosed by RecruiterIndustry: IT-Software / Software Services Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology Role Category: Drug Regulatory Affairs/DocumentationRole: Regulatory Affairs ManagerEmployment Type: Full Time, Permanent , Education:UG -B.Pharma - PharmacyPG - M.Pharma - Pharmacy, DM - Clinical Pharmacology

Keyskills :
ichctcneesdigital conversionsoftware servicesservice levelspersonal developmentpersonal development planslife sciencesregulatory affairssasinformation securityresumemetricsmusic makingtrainingrimfdamedical

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