Regulatory Affairs Professional creating clinical evaluation documents for medical devices in a fast - growing biotech company. Collaborating with stakeholders and ensuring compliance with regulations.
GS
Hybrid Senior Regulatory Specialist – Regulatory Information Management
Posted 3 months ago
About the role
- Senior Regulatory Specialist managing regulatory information and support for GSK's product portfolio. Collaborating across teams to ensure compliance and quality in regulatory data management.
Responsibilities
- Manage and maintain regulatory information within RIM systems, ensuring accuracy and timeliness for supporting GRA submission activities and responding to urgent, time-sensitive requests.
- 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.
- 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.
- Support system validation activities, such as User Acceptance Testing, and contribute to change control processes, including assessing the impact of system or process changes.
- Perform routine and ad-hoc data extraction and transformation from RIM systems for KPIs in the context of data quality improvement and performance monitoring
- Establish and maintain appropriate procedural documentation where needed: SOP, WI, HtG, Why You?
Requirements
- 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.
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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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