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