Regulatory Systems Specialist

3 days ago


Kingston upon Hull, United Kingdom Reckitt Full time

**Regulatory Systems Specialist**
**Kingston upon Hull, East Yorkshire**
**Competitive Salary & excellent benefits package**

You will contribute to system and user administration for Reckitt Regulatory Systems, providing continuity and consistency of system performance and capability as well as ensuring the ongoing maintenance of accurate and timely Reckitt product and registration data. Responsibilities include:

- Maintaining a comprehensive understanding of current Reckitt and relevant regulatory requirements, including specific standards and requirements of electronic systems
- Provide support to business users to improve data quality and to ensure all data updates required are understood and approved by the relevant record owners (Product Dossier documents, Authority submissions, Product information, Registrations, Variations, Renewals, etc.)
- Work with IT and systems owner on incident & problem management and identify improvements to the functionality of current system as required
- Provide Insights to management to enable them to drive the right behaviours regarding the utilisation of the system
- Provide support to all users of Regulatory systems in a consultative capacity to continually improve quality and compliance, such as but not limited to training, troubleshooting, and resolving issues
- Contribute to data cleansing initiatives as required to enable system upgrades
- Educate users where required in good data management practices to sustain improvements to data quality and data integrity
- Provide support to Project teams during system updates and development activities
- Maintain a good understanding of the system activities, configuration, and parameter setup
- Provide a business voice for project objectives, system requirements, and data integrity
- Support Project teams with assessing the impact of proposed system changes

**You’ll succeed because**
- Scientific background - degree and/or professional membership desired but not required
- Experience of working in the Healthcare, Personal Care, Medical Device, or other Healthcare related industry is desirable
- Chemicals/Medicines Regulations and Compliance Expertise (eCTD, XEVMPD, UDI) is desirable but not required
- Strong Computer System Validation (CSV) and Good Practices (GxP) knowledge and skills is important for this role
- Understanding of regulatory requirements relevant to the Reckitt portfolio of products and electronic systems
- Understanding of Good Automated Manufacturing Practice (GAMP)
- Experience with Data Transformation and Analytics is desirable but not required
- Influencing skills in working with users on data quality and data integrity
- Commercial awareness and understanding of corporate codes of conduct
- Strong interpersonal and communication skills
- Flexibility in thinking, with creative and pragmatic problem-solving skills
- Ability to effectively prioritise and execute tasks while under pressure

**You’ll **love** it because**
you’ll get to make an impact like never before. You’ll be responsible for your own projects - we can’t wait to hear your ideas. The products you help us get out there will make people’s lives better. Our iconic brands will provide an incredible platform for you. And our dynamic, ownership-driven culture will help bring the very best out of you, every day.

**Equality**:
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.



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