Urgent! Senior Regulatory Specialist, Regulatory Information Management Job Opening In Mokotów – Now Hiring GSK
The Regulatory Information Management & Data Office (RIM-DO) team plays a pivotal role in ensuring the effective management of regulatory information and supporting the GSK product portfolio.
The information (data and documents) managed by the team is critical to patient safety, regulatory compliance and effective business operations.
In the role you will be accountable for the quality and accuracy of your own work and for the support of the large number of other users across GSK.
You will continuously educate customers on best practice with regards to GRA systems and processes and (on a continuous basis) will feed back suggestions for improvement.
RIM & DO Senior Specialist
Regulatory Information Management: Manage and maintain regulatory information within RIM systems, ensuring accuracy and timeliness for supporting GRA submission activities and responding to urgent, time-sensitive requests.
Expertise and Mentorship: Act as a subject matter expert for RIM systems and processes, requiring a deep understanding of Regulatory Vault data model and legacy RIM systems, share technical expertise with stakeholders, mentor junior colleagues, and collaborate with GRA Process Leads to support business needs and improvements.
Data Quality and Compliance: Monitor and ensure data quality, perform root cause and trend analysis, and implement corrective/preventative actions while ensuring compliance with data standards, procedures, and system reference data maintenance.
System Validation and Change Management: Support system validation activities, such as User Acceptance Testing, and contribute to change control processes, including assessing the impact of system or process changes.
Data Extraction and Reporting: Perform routine and ad-hoc data extraction and transformation from RIM systems for KPIs in the context of data quality improvement and performance monitoring
Procedural Documentation and Improvement: Establish and maintain appropriate procedural documentation where needed: SOP, WI, HtG,
Bachelor’s degree in sciences or technical field (qualifications in information management, database management, customer services are relevant to this role)
Relevant experience in Regulatory Information Management (RIM) AND/OR previous work experience in a customer facing role utilizing databases within a regulated environment
Excellent written and verbal communication skills (Fluent English) and ability to present information in a clear and concise manner with the ability to interact with various functions
Awareness of relevant health authority regulations and guidance, technology trends, as well as industry standards concerning record keeping practices, document/information management and HA submission requirements.
Demonstrated knowledge of GSK Marketed Products and development products.
Awareness of drug development process
Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines
Good interpersonal skills, service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary, global, and matrix environment.
Why GSK?
We also offer a wide range of additional benefits:
Career at one of the leading global healthcare companies
18 months fix term contract
Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
Life insurance and pension plan
Private medical package with additional preventive healthcare services for employees and their eligible counterparts
Sports cards (Multisport)
Possibilities of development within the role and company’s structure.
Personalized learning approach (mentoring, online training’ platforms: Pluralsight, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities)
Supportive community and integration events
Modern office with creative rooms, fresh fruits every day
#LI-GSK
#LI-HYBRID
As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process.
Please contact our Recruitment Team at to discuss your needs.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.
We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive.
We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines.
We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most.
Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
GSK is an Equal Opportunity Employer.
This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK.
In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
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Unlock Your Senior Regulatory Potential: Insight & Career Growth Guide
Real-time Senior Regulatory Jobs Trends in Mokotów, Poland (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Senior Regulatory in Mokotów, Poland using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 5113 jobs in Poland and 13 jobs in Mokotów. This comprehensive analysis highlights market share and opportunities for professionals in Senior Regulatory roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! GSK is currently hiring and seeking a Senior Regulatory Specialist, Regulatory Information Management to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at GSK adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Senior Regulatory Specialist, Regulatory Information Management Jobs Poland varies, but the pay scale is rated "Standard" in Mokotów. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
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