Regulatory Information Management Officer

Come and Save Lives with Us!

Serb Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. We have over 400 employees in 10 countries.

Our portfolio of 80+ rescue medicines makes a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.

Our Purpose is supported by our 4 key values:

• We make patients our priority

• We act with integrity and accountability

• We work together as one team

• We look for better ways forward

We are looking for a talented Regulatory Information Management (RIM) Officer to join our Global Regulatory Affairs team in Paris.

In General, the RIM Officer role will be :

The Regulatory Information Management Officer will manage all activities and projects related to the Regulatory Information Management System (RIMS), essential for facilitating effective regulatory compliance and information flow.

The Regulatory Information Management Officer must be able to lead the utilization of the RIMS and its development projects in compliance with the Regulatory Affairs processes and the different regulations.

This position will require analytical, problem-solving skills and collaborative interactions with various departments to enhance regulatory processes and data management.

As Regulatory Information Management Officer, some of your responsibilities will include:

RESPONSIBILITIES

• Regulatory Compliance:

• Ensure that all RIM system's information align with international regulatory standards in the Life science sector.

• Create and maintain regulatory master data in compliance with IDMP regulations and Company requirements.

• Ensure RIMS integration to EMA's Data Management Services as well as eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD) data compliance and readiness for submission (Europe only).

• Prepare and maintain Quality documents: standard operating procedures, work instructions and processes as-needed to support compliance.

• Information/Documentation Management:

• Develop the best practices regarding the utilization of the RIMS for effective management of regulatory information, including pharmaceutical products' submissions, approvals, and compliance documentation: Data entry's management instructions, Report, Dashboard, …

• Periodically review recorded information (data and documents) to warrant accuracy and completeness (QC/Profiling).

• Work with management team in development and preparation of status/progress reports and associated metrics (KPI).

• Application/Platform Management:

• Lead the RIMS releases: review and analyse the releases notes, understand the new or updated features and assess their impact on business processes, perform regression/informal tests on auto-on features, implement the configurable features via the change management process in close collaboration with key users.

• Ensure users requirements are adequately documented and serve as the basis for system continuous improvement.

• Manage systems' user access and authorization level throughout the company.

• Training

• Provide comprehensive induction and ad-hoc refresher training to key users and stakeholders.

• Act as a key expert to provide technical support with respect to processes and operational activities.

• QA/IT/Vendor Management:

• Act as primary interface with company QA & IT services and system vendor.

• Oversee relationships with technology vendors and service providers, ensuring the delivery of high-quality solutions and services.

We are always looking for talents and personalities to join on board, but if we had to sum up what we are looking for :

• Master's degree in Life Science, Computer Science, Computer Engineering, or related degree with 2-3 years of experience in an existing Regulatory Information Management System (Veeva, ENNOV or equivalent) / Bachelor's degree with at least 5 years of experience

• Knowledge of regulatory compliance requirements and best practice

• Ability to establish and maintain effective collaborative relationships with internal and external stakeholders.

• Demonstrated problem-solving skills in a global environment

• IT enthusiast with appetite to learn and discover

• Team player, service-oriented

• Analytical and synthetic, able to formalize solutions

• Strong written and verbal communication skills

• Fluency in English.

Location

• Paris, Avenue George V

Serb Specialty Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.