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Regulatory Affairs AM/DM


Source:
TIMESJOBS.COM
Location:
Chennai, TN
Date:
12-11-2016
Job Code:
58276972
Categories:
  • Biotechnology & Science
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Job Details

ResponsibilitiesFunctions as the product owner / support owner (surrogate GPO) for Life Cycle management (LCM) / LCM- Site transfer submissions, working with Global Product Owners (GPO) and cross functional team to ensure preparation of quality global regulatory strategy document and supplements as assigned to the team. Able to drive the regulatory submissions with minimal guidance.Also provides guidance and support to Junior Product Owners in the preparation of quality global regulatory strategy document and dossier / supplementsResponsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), CTD sections of supplements / variations for LCM / LCM- Site transfer submissions and ensures effective data presentation and qualityResponsible for effective coordination with the cross functional teams, site and corporate RA teams for the review and finalization of supplements to ensure effective data presentation and qualityResponsible for effective review and providing timely feedback to the teams on technical documents including batch documents related to submission (batch records, Exhibit batch and stability protocol) and transfer protocols in terms of site transfer (Technology transfer protocols),Provides regulatory assessment and supports Change Control Assessment.Ensures commitments (module 2-5) made to health authorities are entered into tracking systems and are tracked to closure, as appropriate.Provide regulatory support to for the assigned products, participates and provides inputs in technical reviews and strategic discussions on LCM / LCM- Site transfer submissions and Change Control reviews as assigned.Collaborates with and ensures adequate support to the regional team to ensure completion of assigned shared task or goal.Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management and core team.Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projectsResponsible for ensuring compliance to the submission standards, procedures and policies framed by Global Regulatory Affairs.Ensures compliance to companys internal procedures and training SOPs (ISOTrain).
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 7-11

Requirements

Regulatory Affairs
Applying for this job will take you to an external site

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