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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Quality Assurance & Regulatory Affairs Manager M/F - Benelux

 

About Guerbet

 

At Guerbet, we BUILD LASTING RELATIONSHIPS SO THAT WE ENABLE PEOPLE TO LIVE BETTER - This is OUR PURPOSE.


AchieveCooperate, Care and Innovate are the values that Guerbet employees share every day. Working at Guerbet means playing a unique role in the future of medical imaging. Passionate about what we do, the company strives day after day to combine performance, quality and sustainable development.


We are an international and fast-growing pharmaceutical company specialized in medical imaging. With a worldwide presence, we offer a comprehensive range of contrast media, injection systems, digital solutions and services for Diagnostic Imaging (CT/Cath Lab imaging, Magnetic Resonance Imaging) and Interventional Imaging (Contrast agents and medical devices). 

 

  • Diagnostics imaging is Guerbet’s historical business which is transforming towards a solutions-oriented model to combat a market that is becoming commoditized. In order to proactively reposition itself in light of the changing market, Guerbet has built a combined offering through Contrasts products, Medical Devices and software. 
  • Interventional imaging is a key growth axis for Guerbet and they have made significant investments in their product portfolio (both internally and through Acquisitions) and their Go-To- Market (Sales Teams, Marketing, Product Management, etc.). This interventional imaging business already represents more than 10% of the revenue of Guerbet is a key part of their growth strategy. 
  • Finally, Digital Solutions is a nascent business for Guerbet with a small but growing portfolio of solutions. Guerbet’s portfolio of Software consists of both in-house developed products, distributed products of other companies as well as joint development programs in Augmented Intelligence with IBM Watson Health. 

 

 

Location : Guerbet, Benelux


 

Summary 

Reporting to medical affairs manager, you will be responsible for Regulatory Affairs and Pharmaceutical and Quality Affairs

 

Your Key Responsibilities will include:

 

1.     Regulatory Affairs 

 

•    Is in charge of the local regulatory intelligence and all related tasks.
•    Is the contact person dealing with the authorities for RA on his/her perimeter.
•    Checks the legal and regulatory compliance as well as the scientific content of the documentation sent by the Corporate RA department.  
•    Informs the Corporate RA department about new regulations on his/her perimeter. 
•    Proposes regulatory strategies based on his/her expertise and knowledge of the laws from Belgium, Luxembourg and the Netherlands about medicines. 
•    Revises and validates the texts of the packaging materials of the products. 
•    Applies for pricing and reimbursement of the products and follows the decisions of the commissions. 
•    Is in charge to submit all PV related issues such as the PSURs, new SmPCs and other safety related documents to the competent authority.
•    Is responsible for writing and updating the quality documentation related to RA. 
•    Defines and coordinates the needs for training of all collaborators and the resources involved in RA in his/her subsidiaries. 
•    Supports all Quality related activities linked to RA, mainly the systematic updating of specifications (Change management), of variations, of packaging (a.o.) influencing market release and GMP compliance. 

 

2.    Pharmaceutical and Quality Affairs

 

•    Implements locally the Good Pharmaceutical Practice (GPP) policy of Guerbet Benelux defining a general pharmaceutical quality policy, strategy and objectives taking in account due diligence and general rules of continuous quality improvement (management review, risk management based principles a.o.).
•    Ensures that a quality management system is implemented and maintained with clear definition and demarcation of local and global standard operating procedures and instructions.
•    Is responsible for the fulfilment of all legal requirements concerning the pharmaceutical activities of Guerbet Benelux in relation to the function of Responsible Person as defined in the Belgian, Luxembourg and Dutch Law on Medicinal Products and Medical Devices. 
•    Prepares and follows the course of inspections and audits including all subcontractors, suppliers of medicinal products and related starting material in close collaboration with Guerbet headquarter’s quality department. Is responsible for the local implementation of the preventive and corrective actions.
•    Establishes and maintains a GDP/GMP/GCP/GVP compliant quality system including all relevant quality assurance documentation. 
•    Checks the compliance with the good practices (GMP, GDP, GCP) according to Belgian, Luxembourg and Dutch Legislation and valid EU guidelines. 
•    Ensures that written job descriptions are prepared and updated for all staff members involved in pharmaceutical and pharmacovigilance activities. 
 

Your Key to Success:

 

•    Holder of a Pharmacist or Medical doctor degree
•    Sufficient qualifications/ experience in GDP & quality management
•    Good level of knowledge of BE -NL pharmaceutical regulations

•    Fluent in French and Dutch
•    Good level in English

 

REASONS TO JOIN US


 
Much more than a competitive salary, we offer continued personal development, we offer an interesting opportunity to join our Quality and Regulatory Affairs team.

When you join Guerbet Group, you:
 
•    Are choosing the world’s leader in the technological sector of diagnostic and interventional imaging, 
•    Are joining our 2600 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life in more than 80 countries all over the world,
•     Are joining a company where we value our diverse team coming from various horizons.
 
We # Achieve # Cooperate # Care # Innovate at Guerbet. 
 
To learn more and to apply, feel free to visit our website : www.guerbet.com