Regulatory Affairs Associate II - 1435
Navi Mumbai, India, 400706
Who are we?
Job Description
Required:
- Experience of the pharmaceutical industry with direct experience in Regulatory Affairs, with a solid understanding of the pharmaceutical regulatory affairs process.
- Experience of managing regulatory product registration data, ideally within a regulatory information management environment.
Preferred:
- Extensive experience of the pharmaceutical industry with direct experience in Regulatory Affairs, possessing a solid understanding of the pharmaceutical regulatory affairs process.
- Extensive experience of managing regulatory product registration data, ideally within a regulatory information management environment.
- Understanding of the requirements of Article 57 (2) of Regulation (EC) No 726/2004 (Extended EudraVigilance Medicinal Product Dictionary or xEVMPD) and the related record submissions process.
Qualifications
Minimum Educational Qualifications:
Required: Bachelor’s Degree in Life Sciences or Information Technology.
Preferred: MS in scientific or information technology discipline.
Minimum Years of Work Experience:
Required: 2-5 years
Function
Sub Function
Reports To
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