Regulatory Systems ociate

Job Purpose:

The purpose of this role is to manage the regulatory information management (RIM) system for all Consumer Healthcare products worldwide to support key regulatory processes and enable the company to meet its regulatory legal and pharmacovigilance obligations. This role is responsible for the operation of the regulatory systems and processes used to prepare and store regulatory submissions labelling planning/tracking and generating KPIs/metrics and compliance reports. This role will work closely with central regional and key local regulatory CH teams and key external regulatory agencies/trade associations to ensure key information is provided to meet internal/external compliance databases (e.g. EU Art 57) and PV systems.

Key responsibilities:

System administration:

Identify and drive system or process changes to enhance data quality user experience and compliance.

Provide guidance and support for related initiatives including system upgrades and enhancements in support of regulatory processes and obligations.

Monitor system performance and ensure that performance or capability issues are resolved effectively.

Partner with IT colleagues on system implementation and change control activities including development of iQMS IT quality documentation to support user acceptance including test scripts and reports.

System reports:

Support in managing the design validation and delivery of regulatory reports for compliance and dept. KPIs.

Ensure timely delivery of adhoc and regular reports.

Data compliance:

Ensure capture of high data quality regulatory data.

Identify and communicate data errors and inconsistencies and drive data remediation initiatives as required.

Manage the delivery of compliance reports required to support business stakeholders. User training and support:

Delivery of effective system user training and system access promoting compliant use of RIMs application.

Ensure up to date process documentation training materials and user guides.

Provide Systems Administration including management of user access and roles.

Provide daytoday support to the users.

Champion the importance of registration tracking within the organisation through regular communication with global stakeholders.

Knowledge required:

• Clear and accurate editorial skills to ensure data reported is consistent and meaningful.
• Excellent organisational and coordination skills.
• 2 years experience in regulatory operations (or similar) role
• Experience within pharmaceutical organisation in particular Regulatory Affairs.
• Understanding of global regulatory affairs processes.
• Familiarity with the range and types of nonprescription healthcare products including overthecounter (OTC) medicines cosmetics and devices.
• Awareness/experience of EMA EudraVigilance Medicinal Product Dictionary (EVMPD) requirements.
• Advanced knowledge of Regulatory Information Management.
• Familiarity with database applications concepts and reporting.
• Experience of project and business analysis.
• Excellent understanding of standard IT applications including advanced use of Microsoft Excel to manipulate reports and summarise data.
• Knowledge of Insight Manager application.
• Knowledge of cloudbased applications.
• Familiarity with systems validation and project quality methodologies (e.g. iQMS Agile).

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Remote Work :

No