القائمة الرئيسية

الصفحات

Regulatory Specialist, Market Specific Coordination at GSK

 Regulatory Specialist, Market Specific Coordination at GSK

Job Purpose

Regulatory Specialist (Market Specific Coordinator) is responsible for the efficient management and delivery of Market Specific Requirements.

Key Responsibilities

-Liaise with MSR suppliers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner.
-Prepare the Market Specific Requirements package for regulatory submissions.
-Ensure appropriate archival of MSR data package.
-Organize dispatch of MSRs.
-Update tracking systems (e.g., OPAL) with dispatch dates and D-numbers as defined by process documents.
-Escalate changes through the relevant process.
-In addition to above activities, if SC role is being done then following activities needs to be performed.
-Coordinate the preparation of regulatory submissions (e.g., Renewals, Product Expansion Dossiers for Emerging Markets, Site registrations, Tenders).
-Monitor plans for upcoming submissions
Check with relevant groups to understand ongoing regulatory activities that may affect the submission package, agree and document strategy.
-Liaise with documentation suppliers to ensure components are delivered in a timely fashion.
-Communicate availability of data package to LOC.
-Maintain knowledge of relevant submission formats and outputs and guidance associated with different formats of regulatory submissions which may differ with each Authority.
-Compliance checks and reformat Regulatory documents if and when required.

Knowledge/ Education / Previous Experience Required:

-University Bachelor’s degree in Chemistry, pharmacy or other related sciences.
- 1 to 3 years’ experience in a similar role
Working experience within Regulatory Affairs
Good command in English (written and spoken) is a must
-Good command in French (written and spoken) is an advantage
-Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes
-Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
-Proven ability to work on multiple projects simultaneously
-Ability to build effective working relationships and work in a matrix environment effectively
-Ability to think flexibly in order to meet constantly shifting priorities and timelines.
-Excellent communication and interpersonal skills
-Ability to work across boundaries with high level of discipline, commitment & accountability

Apply from here


reaction:

تعليقات