Regulatory Associate -Artwork Review needed for Pharma major location – Mauritius
terms $40-50/ hour
current resume to Remya@mpdgroupmail.com
job ---Artworks review and approval
Purpose:
Specific Outcomes / Accountability:
Knowledge of ICH, EU and GMP guidelines
Proven Experience in handling artwork s for regulatory submissions
Review and Approval of artworks for all regulatory submissions
Checking the compliance of artworks with in-country requirements
Coordination with in country agents for finalization of artworks
Regular Maintenance of artworks trackers
Collect and Maintenance of Packaging Intel
Implementation of new requirements and guidelines versus existing files
Provide regulatory support to all operational departments within the company where necessary.
Foster good working relationships with relevant regulatory bodies.
Qualifications & Experience:
Bachelors or Post Graduate degree in Pharmacy /equivalent
3 to 5 years experience in Artwork activity for EU and ROW markets
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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