Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients.
Want to help us make a difference?
Using plant-based resources, we collaborate with our customers and partners to imagine and offer ingredients to better feed people and treat patients.
Each of our ingredients responds to unique and essential needs, and they enable healthier lifestyles.
The MSP leads the regulatory team to build and maintain a robust yet agile regulatory management system.
With a continuous improvement mindset, he/she strives to identify all improvement opportunities in relation which work processes, taking into account the requirements of the regulatory team and those of RA’s internal customers.
Thanks to his/her IT skills, he/she creates tools enabling to measure the regulatory affairs activity. He/she also maintains these tools up to date both technically and qualitatively. He/she transforms the Raw data collected into relevant KPIs and regularly issues commented reports based on them.
His/her analytical mind and good expression skills allows him/her to write or support the writing of all relevant documentation such as the RA Manual, directives, instructions, lists or forms
Always willing to optimize the operational and organizational aspects of a high performing RA function, he/she will be perceived as a value-creator.
He/she develops his/her tasks in alignment with the Legal operations manager.
Key Accountabilities:
The HGMSP takes responsibility of:
· the Global Regulatory Affairs Management System (RAMS):
- manages all documentary material
- writing/reviewing,
- management of obsolescence/planning of revisions,
- drafts and updates internal compliance policies
- promotes and facilitates the implementation of RA directives and instructions
- prepares and leads the annual management system review
- manages a centralized document storage system for regulatory dossiers
- supervises the collection, storage, and analysis of data for regulatory submissions.
- supports the head of Corporate RA to build the annual action plan and follows it up
- coordinates support to external audits and inspections (e.g. FSSC 22000)
- organizes regulatory watch collect and ensures timely dissemination to relevant stakeholders
- maintains a consolidated list of applicable regulations across business areas and regions.
- organizes and disseminate the Regulatory Newsletter
· the operational excellence:
- collects RA activity Raw Data (incl. furniture of templates)
- generates KPIs based on Raw Data
- regularly issues reports on RA activity
- trains RA members on Excellence topics
- manages the RA Corporate budget
- is the key contact of the global Excellence functions
· all activity requiring advanced IT knowledge:
- creates/maintains our internal databases (One Stop Shop, Cosmetics BDD etc.)
- manages the contract of our external databases (Leatherhead, Food Chain ID etc.)
- creates/maintains our IT tools and templates
- manages data storage, ensures data integrity and traceability
- creates and manages e-learnings for the Regulatory function
Functional & Technical Competencies:
- Innovative, autonomous, agile, open-minded, strong business acumen
- Driven by performance / optimization, problem-solving and results oriented
- Empathic, leading capabilities and good communication skills
- Excellent social and communication skills in English, both written and verbal
- Exhibit strong ethical standards and integrity
- Ability to conceptualize, design and implement Management System processes and their measurement tools such as KPIs
- Ability to explain & teach abstracts concepts
- Ability to summarize numbers and figures into workable and operational documents
- Ability to enlighten business on how regulations impact its development or innovation and propose adapted risk management strategies / advices on opportunities
- Ability to explain, communicate and turn a vision into a concrete actions plan
- Strong project management skills and ability to lead cross-functional teams
If you identify yourself in this position, please apply by uploading your resume and let's start the journey together !
Roquette is proud to be a global company where you can find personal and professional growth through multiple diverse experiences.
Roquette believes Diversity, Equity and Inclusion must be woven into everything we do, from the products we make, through the relationships we build with our partners, and most importantly within the teams we create and how we interact together.
As we continue to grow, Roquette understands that to be successful we must always be inclusive in our approach, by creating a workforce that represents the world we live in, and the communities and customers we serve.
To find out more about our products, values and sustainable development ambitions visit us at www.roquette.com and at www.sustainability.roquette.com
Top Skills
What We Do
About Roquette: “Offering the best of nature”
Roquette is a family-owned global leader in plant-based ingredients and a leading provider of pharmaceutical excipients.
Founded in 1933, the company currently operates in more than 100 countries, through more than 30 manufacturing sites, has a turnover of around 5 billion euros, and employs almost 10,000 people worldwide.
Life and nature have been our sources of inspiration for decades.
All our raw materials are of natural origin. From them, we enable a whole new plant-based cuisine; we offer pharmaceutical solutions that play a key role in medical treatments; and we develop innovative ingredients for food, nutrition and health markets. We truly unlock the potential of nature to improve, cure and save lives.
Thanks to a constant drive for innovation and a long-term vision, we are committed to improving the well-being of people all over the world.
We put sustainable development at the heart of our concerns, while taking care of resources and territories. We are determined to create a better and healthier future for all generations
