Regulatory pharmacist (F/M) At Doctors Without Borders

The “Médecins Sans Frontières Logistique” Association is one of the purchasing centers of the MSF movement whose objectives are:

• the supply and support of MSF missions or other NGOs with medical and non-medical equipment enabling them to ensure the smooth running of their programs
• participation in technical and logistical training for MSF staff
• research, innovation and development of new tools adapted to MSF’s areas of intervention

A non-profit association under the 1901 law created by MSF France in 1986, based in Mérignac (Bordeaux Métropole – France) and Dubai (United Arab Emirates), MSF Logistique currently has 175 employees whose functions cover the entire supply chain missions (reception and processing of orders, purchases, storage, maintenance of emergency stocks, assembly into kits, preparation of orders, transport) as well as cross-functional support functions (Administration and Finance, IT, Human Resources, Quality Assurance).

MSF Logistics carries out its mission within the framework of existing legislation and regulations in its field in the countries where it is based, in particular: Pharmaceutical establishment, Approved economic operator, Bonded warehouse, Facilities classified for environmental protection (ICPE), Humanitarian Purchasing Center (HPC ECHO).

Mission

Within the Data Quality and Governance Department, the Pharmacist (ne) Regulatory (F/M) contributes to the regulatory compliance of activities and the maintenance of continuity of operations under pharmaceutical responsibility. In a context of strong growth in activity and deployment of structuring projects (Information Systems Review and NextSpin), he/she actively participates in securing processes, controlling critical data and preparing audits regulatory.

Your main missions will include:

Management or contribution to regulatory and quality projects, particularly linked to the preparation of audits

• Monitor the qualification of customers and suppliers and manage associated compliance actions
• Ensure monitoring of compliance actions linked to the BPD transport requirement
• Update procedures and operating methods within management and support other areas in implementing regulatory requirements in their documentation
• Contribute to the Qualios project (Quality EDM tool) by structuring the documentary tree, updating and migrating the documentation
• Lead compliance and/or audit preparation action plans (management, reminders, consolidation of evidence, reporting)

Contribution to strategic projects (IS Review & NextSpin)

• Contribute to the definition of process and data quality and regulatory requirements and their integration into systems (dataprescription included Nextspin and Révision SI)
• Contribute to the deliverables of the system and interface validation plan (IS review: risk analysis, operational and performance qualification, assistance with the validation of the various deliverables…)
• Contribute to the validation of the migration of critical data for the Nextspin project
• Contribute to the necessary project, process and data exchange controls (NextSpin and Revision SI)

Carrying out self-inspections and monitoring exchange controls

• Carry out the self-inspections defined in the self-inspections schedule established by the Responsible Pharmacist, within the BPD scope
• Participate in the implementation of the “change control” culture
• Monitor the progress of change controls currently being deployed
• Communicate internally on the exchange controls to be launched

Contribution to the operational activities of the regulatory department

• Ensure monitoring of import/export constraints
• Participate in the management of quality alerts, batch recalls and product complaints

Pharmaceutical liability

• Ensure the replacement of the Responsible Pharmacist by being “given for replacement periods the same powers and attributions as the Responsible or Delegated Pharmacist and by effectively exercising them during replacement periods”
• Ensure the role of Assistant Pharmacist by participating in the monitoring and implementation of national and international pharmaceutical legislation (ANSM requirements, country of intervention requirements)
• Contribute to the assessment of compliance with the PGGD

Profile

Coming from a Pharmaceutical background (Bac+5 minimum), you hold a Pharmacist diploma recognized in France and are registered(e) or registrable with the Order of Pharmacists.

You have at least three years of experience in similar functions, ideally acquired in a pharmaceutical industrial environment.

You master the principles of QMS, the process approach and continuous improvement, as well as the requirements related to import/export and compliance (BPD, audits, documentation).

Comfortable with IT tools and IS environments, you are able to contribute to structuring projects integrating data and system validation issues. You are proficient in the Office Pack and have an operational level of English.

Autonomous and rigorous, you know how to prioritize your activities and meet deadlines. Your analytical skills, your sense of transversal collaboration and your interpersonal skills allow you to interact effectively with a variety of people.

Your commitment, your team spirit and your sense of responsibility will be key assets to succeed in this position with a strong strategic dimension.

Contract

Taking office: ASAP

Contract: FIXED-TERM CONTRACT

Duration: 18 months

Location: Position based in Mérignac (33700)

Organization of working time: Day package of 205.5 days annually

Remuneration : 4,210.43€ gross monthly over 13 months or 54,736€ gross annually

Advantages:

• 22.5 day rest package
• Restaurant vouchers
• Supplementary health insurance covered by 100% employer
• Teleworking according to the internal charter in force

Recruitment process

At MSF Logistics, we value diversity and work for an inclusive and accessible work environment. We encourage all qualified individuals to apply, regardless of their origin, age, gender, sexual orientation, beliefs, disability or other aspects of their identity.

Each application is studied with the greatest attention, taking into account the backgrounds, skills and motivations of each person(e).

We attach particular importance to the quality of exchanges, the adequacy between the position, the team and the values of our association, as well as the professional commitment of each candidate(e).

Our objective is to offer a clear, fair, respectful and transparent recruitment process, allowing everyone to better understand the position and project themselves into our work environment.

Our recruitment process takes place as follows:

1. Analysis of applications

   Each application is carefully studied by our HR and operational teams, without the use of automated sorting tools.

   👉 If there is no response from us within 3 weeks after applications close, please consider that your profile has not been selected for the remainder of the process.

2. First telephone exchange

   A qualification interview is carried out by the person in charge of recruitment in order to discuss your background, your motivations and present the position to you more concretely.

👉 At the end of this exchange, you systematically receive written feedback informing you of the follow-up given to your application.

1. Recruitment interview

   Successful candidates continue the process with an interview bringing together:

   • the future(e) manager
   • a Human Resources representative(e)
   • a professional contact person(s)

This exchange allows you to assess your skills, your fit with the team, and your projection into the position, while giving you a concrete vision of the work environment.

1. Final decision

At the end of the interviews, a decision is taken in a concerted manner between all stakeholders.

👉 Final feedback is systematically communicated by telephone to each candidate met).