GLOBAL RESPONSIBILITY The Junior Associate, Regulatory Operations and Systems Management, in close collaboration with the Regulatory Operations team, is responsible for the maintenance of the Regulatory Information Systems and their Data, Documents and Dossiers, which is essential for ensuring an efficient Information Flow and a Regulatory Compliance.
The role reports to the Associate Director, Regulatory Operations & Systems Management.
SPECIFIC RESPONSIBILITIES Regulatory Systems Compliance and Management Ensure that all systems' information align with international regulatory standard in Life Sciences sector.
Create and maintain regulatory master data in compliance with worldwide IDMP regulations and Company's requirements.
Participate to the management of Upgrades Releases by reviewing the features, assessing their impact on business processes, performing informal and formal tests via the change management process, in close collaboration with users.
Ensure the conformity of related Regulatory Quality Documents (Process and Procedures) and Participate to their global continuous improvement.
Manage Systems' Users Access.
Information Management Participate to the development of best practices regarding the utilisation of the RIM System.
Ensure the Completion of Data into the RIM System, in compliance with Countries' Regulations.
Target the compliance to Regulatory Data integrity via regular Quality Check of the DataBase.
Participate to the management of in-house Publishing activities.
Participate to the compliance of Submitted Dossiers Storage.
Manage the Preparation of documentation to support global submissions and to support Supply Chain, QA and Manufacturing Departments, including but not limited to Certificates of Pharmaceutical Product, Power of Attorney, applicable legalization procedures, and Approved Marketing Authorisation Details.
Training and Support Provides guidance and expertise on Regulatory Operations to both internal and external stake holders.
Ensure awareness of the Users.
Deliver regular and ad-hoc Instructions and Training sessions on the importance and the utilization of Regulatory Systems, master data & transactional data, documents and dossiers.
REQUIREMENTS Education: Bachelor´s degree in Life Sciences or Computer Science / Technology (e.g.
Chemistry, Biology, Biochemistry, Pharmacy), or equivalent.
Languages: Fluent English.
Knowledge of Spanish will be an asset Experience (years/area ): Minimum 1-year experience in Regulatory Operations / Regulatory in the pharmaceutical industry.
Specific Knowledge : Experience in the preparation, publishing, and eCTD submission for IND/CTA, BLA/MAA to regulatory agencies Experience in the regulatory data traceability Direct hands-on experience working with document management systems, document formatting and publishing tools, eCTD validation and viewers.
Knowledge of EMA, FDA and ICH regulations and guidelines on eCTD structure and specifications.