Regulatory Specialist - MSR Coordination
GSK -
Cairo, EgyptPosted 5 years ago93People have clicked1 open position
Job Details
Experience Needed:
Career Level:
Education Level:
Salary:
Job Categories:
Skills And Tools:
Job Description
Job Purpose
- Regulatory Specialist - MSR Coordination 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.
- Organise dispatch of MSRs.
- Update tracking systems (e.g., OPAL) with dispatch dates and D-numbers as defined by process documents.
- Escalates changes through the relevant process.
- In addition to above activities, if SC role is being done then following activities needs to be performed.
- Coordinates 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.
- Maintains 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 reformats Regulatory documents if and when required.
Job Requirements
- Fluent French is a must
- Bachelor’s degree in Chemistry, pharmacy or other related science
- 2-5 years of experience within Regulatory Affairs in the Drug development environment.
- Demonstrated ability to proactively manage workload, timelines and identify priorities. Build relationships with relevant internal functions.
- Proven ability to work on multiple projects simultaneously.
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
- Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
- Excellent written and verbal communication skills and ability to present information in a clear and concise manner
- Ability to interpret and advise on guidelines and requirements on a global basis, reflecting recent GSK experience
- 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