Regulatory CMC development Expert CDI- FM

Pierre Fabre; Toulouse; Sur place; EUR 40 000 - 60 000; Plein temps

Résumé du poste

A prominent pharmaceutical company in Toulouse is seeking a Regulatory-CMC Development Expert to lead CMC regulatory strategy for assigned projects. The ideal candidate will have a Master's degree and at least 8 years of experience in CMC Regulatory Development. Responsibilities include preparing regulatory dossiers and ensuring compliance. This role offers an attractive remuneration package and the option for remote work. Fluency in English is mandatory.

Prestations

Incentives profit-sharing

Health and provident insurance

Public transport participation

16 days of holidays (RTT)

25 days of personal holidays

Qualifications

• Minimum 8 years of relevant experience in CMC Regulatory Development or CMC R&D.
• Knowledge in small molecules and biological products appreciated.
• Ability to work in an international environment.

Responsabilités

• Lead CMC regulatory strategy for assigned projects.
• Prepare CMC regulatory dossiers in collaboration with teams.
• Ensure regulatory compliance with global CMC plans.

Connaissances

Experience in CMC Regulatory Development

Good written and verbal communication skills

Organizational and problem-solving skills

Ability to work autonomously and in teams

Fluency in English

Formation

Master Degree or equivalent scientific qualification

Outils

Veeva Vault RIM or similar regulatory tools

Description du poste

Who we are

Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.

Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie Pierre Fabre Dermatologie Eau Thermale Avène Klorane Ducray René Furterer A-Derma Naturactive Pierre Fabre Oral Care.

Established in the Occitanie region since its creation and manufacturing over 95% of its products in France the Group employs some 10000 people worldwide. Its products are distributed in about 130 countries.86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation a government‑recognized public‑interest foundation while a smaller share is owned by its employees via an employee stock ownership plan.

In 2019 Ecocert Environment assessed the Groups corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the Excellence level.

Pierre Fabre is recognized as one of the Worlds Best Employers 2021 by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.

Your mission

Within our Worldwide Regulatory Affairs Department we are looking for our new Regulatory‑CMC Development Expert for a permanent position in Toulouse to strengthen our Regulatory‑CMC Development team and support strategic projects for the group.

Summary & Purpose of The Position

Responsibility for CMC regulatory strategy for the assigned projects throughout the different phases of development from early clinical trials to initial marketing applications.

Provide CMC regulatory expertise to Pharmaceutical Development team and lead the preparation of the CMC part of the dossier by collaborating closely with Pharmaceutical Development and Regulatory Development Team.

Your role within a pioneering company in full expansion : CMC Regulatory Strategy :

• Elaborate in collaboration with the pharmaceutical CMC team the CMC development plan until MAA.
• Propose innovative CMC regulatory pathways to accelerate product delivery for patient as required.
• Ensure regional regulatory specificities and needs are incorporated into the global CMC plans.
• Ensure the CMC regulatory risks are identified assessed & shared as appropriate.
• Work closely with Regulatory Affairs Development Team to integrate the CMC regulatory strategy to the overall regulatory strategy of all assigned projects.
• Participate and represent Regulatory‑CMC Development team in CMC project team Global project team and Regulatory project team as necessary for the assigned projects.
• Lead the CMC regulatory section preparation of briefing documents for regulatory positioning and justification in collaboration with the SMEs. Participate to Health Authority Meetings.
• Assess Regulatory‑CMC impact of all changes proposed to the allocated product providing strategic regulatory advice any Regulatory impact CMC‑Regulatory supporting data requirements for subsequent amendments.
• Elaborate adequate planning for Regulatory‑CMC files in collaboration with Pharmacuetical Development Clinical supply and Regulatory Affair Development Team.
• Perform Due diligence analysis providing Reg‑CMC risk assessment remediation plan and review the CMC development plan in collaboration with the Pharmaceutical team.
• CMC Dossier preparation
• Ensure the coordination / authoring / review and validation of Reg‑CMC dossiers in collaboration with Pharmaceutical Development team to deliver effective timely and compliant CTA (IND IMPD Amendment Annual report...) and MAA 2.3 & 3.
• Coordinate the authoring of Reg‑CMC dossier if performed by a subcontractor.
• Manage timely and efficiently the Response to CMC questions from Health Authorities worldwide with support from Pharmaceutical Development team as necessary to reach submission approval.

This position is compatible with teleworking up to 2 days a week after the trial period.

We offer an attractive remuneration / benefits package : Incentives profit‑sharing Pierre Fabre shareholding with matching contribution health and provident insurance 16 days of holidays (RTT) in addition to 25 days of personal holidays public transport participation very attractive CE...

Who you are

Your skills at the service of innovative projects :

• We are looking for candidates with a Master Degree or equivalent scientific qualification and a minimum of 8 years of relevant work experience preferably in CMC Regulatory Development or CMC R&D.
• Knowledge in small molecules and Biological product will be appreciated
• The ability to work effectively both autonomously and in teams along with good interaction skills with internal and external stakeholders is crucial
• Good written verbal and interpersonal communication skills highly organized
• We are looking for someone who is highly driven with enthusiasm to meet requirements with profound organizational and problem‑solving skills.
• Ideally familiar with Veeva Vault RIM or similar regulatory tools
• Fluency in English is mandatory
• Be able to work in an international environment

We are convinced that diversity is a source of fulfillment social balance and complementarity for our employees which is why our offers are open to all without restriction.

Employment Type: Full-Time

Experience: years

Vacancy: 1