Emplois actuels liés à Regulatory Manager - Zaventem, Flandre - Parexel
-
Manager, Regulatory Affairs
Il y a 4 mois
Zaventem, Belgique NSF International Temps pleinRegulatory Affairs Manager EMEA At NSF International, our mission is to protect and improve human health. We’re a global leader in standards development, testing, auditing, certification and training. We provide these services for a diverse set of industries including food, water, health sciences, sustainability and management systems. We’re passionate...
-
Regulatory Affairs
Il y a 4 mois
Zaventem, Belgique Zoetis Temps pleinlocations- Zaventem- time type- Full time- posted on- Posted Today- job requisition id- JR00010928- For our office in Zaventem, Zoetis is currently looking for a _Regulatory Affairs & Compliance, Associate Manager / Manager._ - JOB PURPOSE: - In collaboration with the RA team members, the RA&C Associate - Mgr / Mgr contributes to the Regulatory day-to-day...
-
Regulatory Affairs Specialist
Il y a 4 mois
Zaventem, Belgique Nu Skin Temps pleinKey responsibilities As a Regulatory Affairs Specialist for our food and food supplement brands you will report to the Regulatory Affairs Manager. Your responsibilities will include, amongst others: - On-time filing of regulatory submissions and post-approval maintenance of regulatory dossiers- Ensure product regulatory compliance for food supplements and...
-
Senior Associate Ii Regulatory Intelligence
Il y a 3 mois
Zaventem, Belgique Zoetis Temps pleinlocations- Zaventem- time type- Full time- posted on- Posted Today- job requisition id- JR00014663- Zoetis is currently looking for a Senior Associate Regulatory Intelligence. - POSITION RESPONSIBILITIES: - A Senior Associate on the Regulatory Intelligence Team will be responsible for supporting the management of global evolving regulations within Global...
-
Regulatory Affairs Specialist
il y a 1 mois
Zaventem, Belgique Michael Page Temps pleinRA Specialist - Regulatory Compliance - EU MDR Based in Brussels - EMEA Scope Our client is a global market leader is the field of medical devices. Their EMEA HQ based in Brussels is looking to extend their team and sustain their growth within the Regulatory Affairs department. As the successful Regulatory Affairs Specialist - Medtech, you will have the...
-
Site Regulatory Submission Associate
il y a 3 semaines
1930 Zaventem, Belgique Oxford Global Resources Temps pleinFor one of our clients, a medical device company, we are looking for a bilingual Junior Site Regulatory Submission Specialist (German - English) to come on board and join their team. Job Description The Submission Specialist supports regulatory activities at study start up in assigned region (DACH). Maintain local regulatory documents on paper or...
-
Regulatory Affairs Specialist
il y a 1 mois
Zaventem, Belgique Michael Page Temps pleinRA Specialist - Regulatory Compliance - EU MDR Based in Brussels - EMEA Scope Client DetailsOur client is a global market leader is the field of medical devices. Their EMEA HQ based in Brussels is looking to extend their team and sustain their growth within the Regulatory Affairs department. DescriptionAs the successful Regulatory Affairs Specialist -...
-
Regulatory and Start Up Specialist
Il y a 3 mois
Zaventem, Belgique Novasyte Temps pleinJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 1 years' experience with submissions. Fluent in...
-
Regulatory and Start Up Specialist
il y a 3 semaines
Zaventem, Belgique IQVIA Temps plein**Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **Fluent in both English and Dutch or...
-
Site Regulatory Submission Associate
il y a 3 semaines
Zaventem, Belgique Oxford Global Resources Temps pleinFor one of our clients, a medical device company, we are looking for a bilingual Junior Site Regulatory Submission Specialist (German - English) to come on board and join their team. This person will be responsible for clinical trials in the DACH region (Germany, Austria, Switzerland). Job Description The Submission Specialist supports regulatory...
-
Site Regulatory Submission Associate
il y a 3 semaines
1930 Zaventem, Belgique Oxford Global Resources Temps pleinFor one of our clients, a medical device company, we are looking for a bilingual Junior Site Regulatory Submission Specialist (German - English) to come on board and join their team. This person will be responsible for clinical trials in the DACH region (Germany, Austria, Switzerland). Job Description The Submission Specialist supports regulatory activities...
-
Senior Manager Compliance
Il y a 3 mois
Zaventem, Belgique BDO Belgium Temps pleinThis job in a nutshell: We are currently searching for an experienced senior manager to further build the Compliance business unit for Banking. As the Compliance Senior manager, you will help drive the compliance agenda forward and you will play an important role driving the change at Banks. You have extensive experience in the implementation of new rules &...
-
Clinical Operations Manager
Il y a 4 mois
Zaventem, Belgique IQVIA Temps pleinIQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to...
-
Payments Transformation Manager
Il y a 3 mois
Zaventem, Belgique BDO Belgium Temps pleinThis job in a nutshell: Are you ready to shape the future of payments in the digital age? Join BDO as a Payments Transformation Manager and lead innovative strategies to navigate the evolving landscape of open finance and digital payments. With expertise in PSD2, PSD3, and open banking, you'll drive impactful change and help financial institutions thrive in...
-
Quality/compliance Manager
Il y a 5 mois
Zaventem, Belgique TUI Temps pleinReporting to the AOC Accountable Manager, the Quality/Compliance Manager will ensure that the activities of the operator are monitored for compliance with the applicable regulatory requirements, and any additional requirements as established by the operator, and that these activities are being carried out properly to ensure safe operational practices and...
-
Quality/compliance Manager
Il y a 5 mois
Zaventem, Belgique TUI Temps pleinReporting to the AOC Accountable Manager, the Quality/Compliance Manager will ensure that the activities of the operator are monitored for compliance with the applicable regulatory requirements, and any additional requirements as established by the operator, and that these activities are being carried out properly to ensure safe operational practices and...
-
Quality/compliance Manager
Il y a 3 mois
Zaventem, Belgique TUI Temps plein**TUI Business**: - TUI Airline**Band**: - 4**Pay Band Tariff**: - 4A**Location(s)**: Belgium | Zaventem | 1930 | Luchthaven Brussel 40p/1 **Type of contract**: - PermanentReporting to the AOC Accountable Manager, the Quality/Compliance Manager will ensure that the activities of the operator are monitored for compliance with the applicable regulatory...
-
Quality/compliance Manager
Il y a 3 mois
Zaventem, Belgique TUI Temps plein**TUI Business**: TUI Airline Band: 4 Pay Band Tariff: 4A Location(s): Belgium | Zaventem | 1930 | Luchthaven Brussel 40p/1 **Type of contract**: Permanent Reporting to the AOC Accountable Manager, the Quality/Compliance Manager will ensure that the activities of the operator are monitored for compliance with the applicable regulatory requirements, and any...
-
Quality/compliance Manager
Il y a 3 mois
Zaventem, Belgique TUI Temps plein**TUI Business**: - TUI Airline **Band**: - 4 **Pay Band Tariff**: - 4A **Location(s)**: Belgium | Zaventem | 1930 | Luchthaven Brussel 40p/1 **Type of contract**: - Permanent Reporting to the AOC Accountable Manager, the Quality/Compliance Manager will ensure that the activities of the operator are monitored for compliance with the applicable...
-
Finance Manager
Il y a 3 mois
Zaventem, Belgique ABB Temps plein**Finance Manager**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender, LGBTQ+, abilities, ethnicity and generations. Together, we are embarking on...
Regulatory Manager
Il y a 3 mois
When our values align, there's no limit to what we can achieve.
Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team This is a client dedicated project, and the role can be office or home based in various European locations.
As the CMC Regulatory Manager, you will play a vital role in our company's worldwide post-approval regulatory activities, specifically focused on Chemistry, Manufacturing, and Controls (CMC) for biological products.
Primary Tasks & Responsibilities:
Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports. Assess change controls and provide regulatory assessments of quality changes in production and quality control. Review study reports from the quality control and production departments to ensure compliance with regulatory requirements. Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies. Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities. Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions. Identify, escalate, and mitigate risks associated with regulatory procedures and activities.Experience and Knowledge Requirements:
University-level education, preferably in Life Sciences, or equivalent by experience. Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry. Strong understanding of CMC and post-approval regulatory requirements. Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations. Knowledge of biological processes. Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation. Understanding of qualification/validation principles. Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued. Team spirit, flexibility, accountability, and organizational skills. Fluent in English (written and spoken). French, Italian and German would be a strong plus.