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Openings For Regulatory Affairs

2.00 to 4.00 Years   Mumbai City   02 Jul, 2021
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaBio Tech / R&D / Scientist,Engineering Design / Construction
EmploymentTypeFull-time

Job Description

Dear Candidate,Were Opening forRegulatory AffairsRoles & Responsibilities :-

  1. Dossier preparation for eCTD market UK , EU , Australia & Newzealand & VARIATION filing in EU/Australia market
  2. New project Execution , Should review MFR,PDR,BMR,PVR,SPECS MOA ,STABILITY , ERA,NDMA. Should have knowledge of product lifecycle management
  3. RFI Response , customer queries
  4. Should be well versed with EMEA, TGA and ICH Guidelines. Should visit site for required documents for dossier submission and RFI response as and when required
  5. Should be strong in communication and correspondence.
  6. Desired Skills:
  7. Quality , RND (Product development), Dossier Preparation eCTD format. Very well versed with EMEA Guidelines
  8. Efficient Problem solving , Effective communication, creative thinking , Should be Bold /challenge seeker, positive attitude
Regards,Team HR

Keyskills :
regulatoryregulatory riskdossier preparationcompliance monitoringregulatory affairsfederal regulations

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