Regulatory Associate - Variation Projects needed for Pharma major location – Mauritius
terms $40-50/ hour
please forward current resume to Remya@mpdgroupmail.com
Variation Projects
Specific Outcomes / Accountability:
Knowledge of ICH, EU and GMP guidelines
Proven Experience in handling all type of variations in EU & ROW markets .
Collate all documents from manufacturing sites and upload onto document management system for
compilation Ensure regulatory submissions are complete, properly formatted, and comply with applicable regulatory and corporate requirements.
Implementation of new requirements and guidelines versus existing files
Provide regulatory support to all operational departments within the company where necessary.
Work in close association with regulatory, operations, legal, export commercial
Ensure launch and supply teams are continuously updated on regulatory approvals
Integrate regulatory and technical aspects into supply chain to ensure continuous supply
Qualifications & Experience:
Bachelors or Post Graduate degree in Pharmacy /equivalent
3 to 5 years Regulatory Affairs experience in 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 with and influence manufacturing and analytical management, to improve standards of
compliance and to meet expectations of quality standards
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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