Sr. Regulatory Associate -Regulatory compliance needed for Pharma major
location – Mauritius
terms $40-50/ hour
current resume to Remya@mpdgroupmail.com
Specific Outcomes / Accountability:
The following will be the main areas of responsibility:
Review of Manufacturing documents & Quality documents required for regulatory submissions Working with Key departments R&D / Supply/ Reg Affairs to collect necessary documentation for Dossier submissions check the compliance of registered information against the current practices at manufacturing sites
Ensure that sound regulatory practices are fully integrated in all technical submissions and evaluate all documents submitted to regulatory agencies to ensure they are complete, well organized, of high quality, in regulatory compliance, and presented in a manner that facilitates agency review.
Check compliance of regulatory information on all Regulatory planners
To maintain all Master documents electronically and all updates managed through version control
To manage all registered information on Electronic document management system Management of change controls and ensure that all changes are updated to Regulatory agencies through variation process Check the compliance of product labeling to country requirements
Qualifications & Experience:
Bachelors or Post Graduate degree in Pharmacy /equivalent 4 to 6 years Regulatory Affairs experience in CMC compliance activities
Hands on experience on Electronic document management system
Ability to handle multiple projects and bring them to completion in a timely manner
Ability to challenge processes and standards and lead improvement initiatives as well as work
Excellent written and verbal communication – fluency in English
Key Attributes & Competencies:
Fluent in English
Strong commercial acumen
Initiative and self starter;
Excellent interpersonal and communications skills
Ability to work under pressure and meet tight deadlines
Ability to manage projects in a matrixed team environment and with both internal and external partners;Ability to work in a fast paced international environment, under pressure and to tight deadlines;Flexible with working hours;The ability to prioritize, works independently and within a team, multi-task, and stay positive
Good IT skills
PLEASE SEND CURRENT RESUME TO remya@mpdgroupmail.com
With thanks &warm regards
REMYA KRISHNAN DIRECT 00919947540009
TEAM LEAD - HR MPD HRD Division,
OFFICE +91-9847894786/9947540001/484-2838115 /3295930
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