Leader regulatory IS , Business administrator
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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
As a Regulatory Systems Leader / Business administrator within our Worldwide Regulatory Affairs (WRA) organization you will play a role in shaping the future of our Regulatory Information Systems. On a defined perimeter you will drive the evolution reliability and performance of platforms such as RIM (Registration) Promomats and other regulatory systems supporting business activities.
Your mission: make our regulatory teams more efficient more connected and fully empowered through modern intuitive and datadriven systems.
You will join a collaborative international and forwardthinking environment Business Administration team where innovation and operational excellence are at the heart of everything we do.
Your Key Responsibilities
Contributes to defining the strategy for regulatory systems.
- Ensures alignment with regulatory requirements (in compliance with IS validation rules) business needs and technological evolutions.
- Conducts active monitoring of regulatory technological and methodological developments that may impact the scope.
Leads and oversees the implementation of the defined strategy and ensures its effective deployment across teams and projects.
- Translates the strategy into operational actions within the relevant technical scopes defining priorities milestones and roadmaps.
- Coordinates internal and/or external technical and functional teams involved in execution promoting communication and the sharing of best practices.
Provides technical expertise in a complex operational environment to support teams secure technical decisions and contribute to the overall performance of the company.
- Supports teams in analysis troubleshooting and technical decision-making; performs complex analyses when required.
- Contributes to operational risk management related to regulatory systems (obsolescence endoflife critical dependencies etc.).
- Participates in the onboarding of new team members within the scope of expertise and provides backup support on other regulated system areas.
Ensures user support by strengthening adoption understanding and user satisfaction.
- Works closely with project teams business functions (e.g. R&D Pharmacovigilance Medical Affairs) DAIS and any other internal or external stakeholders to ensure overall consistency and measure user satisfaction.
As a Business Administrator
User Support and Operational Management
- Provides first- and secondlevel support to users: incident resolution user guidance access management data relevance and accessibility compliance with administration processes and regulatory requirements.
- Analyzes technical issues and their operational impact; provides expertise recommendations and solutions.
- In coordination with DAIS and the wider WRA team manages functional requests and incidents: requirement collection impact analysis solution proposal and implementation.
- Leads or contributes to user training ensures communication and strengthens tool and process adoption.
Contribution to Releases and System Enhancements
- Acts as an interface with DAIS and the vendor (e.g. Veeva) on technical topics related to system evolution.
- Collects business needs analyzes technical feasibility and cobuilds solutions aligned with regulatory processes and applicable IS regulations.
- Drafts technical requirement specifications integrating business constraints and system capabilities.
- Manages version upgrades.
- Performs impact and executes test plans.
- Validates production deployment.
- Ensures regular updates of documentation related to the scope.
Who you are
You are a proactive curious and solutionoriented professional with a solid experience in regulatory systems and digital transformation.
You are comfortable navigating complex environments engaging with diverse stakeholders and keeping a global view while managing operational details.
Youll be a great match if you have:
Education Level
Masters degree (Bac 5). Dual background preferred: Pharmacist Medical Doctor or Scientist combined with an IT specialization.
Or equivalent relevant professional experience.
Experience
At least 5 years of experience in Regulatory Affairs and at least 5 years of experience in administering regulatory systems (RIM Promomats QMS eCTD tools or similar).
ORAt least 7 years of experience in either Regulatory Affairs or database/system administration with occasional experience in the other area.
Experience in direct or indirect management including project management is required.
Other
A strong sense of ownership and the ability to work both independently and collaboratively
Excellent communication skills with the ability to simplify complex topics
A mindset oriented toward process optimization and operational excellence
A genuine interest in user experience and data integrity
A positive teamoriented attitude and a desire to make an impact
English : Fluent
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.
Required Experience:
Unclear Seniority
Key Skills
About Company
"We are developing the drugs and care of tomorrow with the inexhaustible resources of our imaginations" Mr. Pierre Fabre
