Senior Regulatory Specialist, Regulatory Information Management

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

Key Responsibilities Include :

• 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,

Why You? Qualifications

• 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

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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 pl.recruitment-adjustments@gsk.com 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.

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