...- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical...
Suggéré
Emploi contractuel
Stage
...- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical...
Suggéré
Emploi contractuel
Stage
...outside of IT.
Proficiency in reporting and data analysis, particularly with PowerBI.
Nice-to-Have Criteria:
Experience in a regulatory environment.
Previous role as a Solution Architect within the Office 365 domain.
Candidates should possess a blend of...
Suggéré
À distance
Recrutement immédiat
V-IT NV
Province du Brabant wallon
il y a 1 jour
...Pharmacovigilance Scientists - Associate Director/ Director/ Senior Director
Positions in GSK Safety Evaluation and Risk Management (SERM... ...clinical matrix.
~ Leads the safety component of global regulatory submissions.
~ Expert evaluation skills and analytical thinking...
Suggéré
Recrutement immédiat
...up of internal audits
· Leading or co-leading internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to GMP.
Profile
What skills do you bring to the table?
· Scientific degree
· Experience...
Suggéré
Emploi contractuel
...~Establishing strong working relationships with key internal stakeholders (UPSA International, Commercial team, Market Access, Regulatory Affairs, Medical department, and Finance) as well as external customers (Healthcare professionals, Key Opinion Leaders, Consumers...
Suggéré
...control perspective.
Spearhead initiatives for continual process improvement.
Ensure ongoing compliance with statutory and regulatory requirements, proactively advising management on necessary actions.
Provide mentorship and guidance to multiple teams, fostering...
Suggéré
Temps complet
...For our Diabetes Care division, we are recruiting a Senior Regulatory Specialist for Benelux.
The Senior Regulatory Specialist is responsible for managing an efficient program to ensure that all regulatory activities for Abbott Diabetes Care products are achieved to...
Suggéré
Job summary
An exciting opportunity has arisen to recruit a full time Administrator to support the Quality Regulation and Improvement Department based at London Ambulance Service's Headquarters. This is a full time and permanent position.
We are looking for an experienced...
Suggéré
Temps complet
Recrutement immédiat
...When our values align, there's no limit to what we can achieve.
We are seeking an experienced Regulatory Affairs Consultant to join our team. As a Regulatory Affairs Consultant, you will be responsible for providing expertise in registration Regulatory Affairs, with...
Suggéré
...Belgium, or Raleigh, North Carolina, US, or UK, we are looking for a talented individual to fill the position of IT Solution Expert Regulatory & Quality
About The Role
This role has global responsibility for all IT systems that enable the Regulatory and Quality...
Suggéré
UCB S.A.
1420 Braine-l'Alleud
il y a 2 jours
...us get ahead of disease together with our Internship Programme
Education required: You are regularly enrolled in a Master in Regulatory Affairs, Engineering, Pharmacy, Biology, Chemistry, Bio-engineering or similar field in an Educational Establishment located in...
Suggéré
Stage
...- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical...
Suggéré
Emploi contractuel
Stage
...resolution of issues involving a range of technical, quality, regulatory and operational issues to ensure patient supply without... ...services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support...
Suggéré
Emploi contractuel
Stage
Keyrus Life Science Belgium
1410 Waterloo
il y a 17 heures
...- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical...
Suggéré
Emploi contractuel
Stage
...BV (NL) and responsible for ensuring maintenance of related regulatory licenses (GDP, medical device notification) and as Qualified... ...that appropriate contacts with country Regulatory Affairs, Pharmacovigilance, third party logistics (3PL) for Warehouse & Distribution (W...
...arena.
b) The management and control of all label content regulatory requirements and translations within the SMART LS label... ...services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support...
Emploi contractuel
Stage
...define and drive the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business... ...evaluation methodology and risk management and preparation of regulatory safety reports and other documents.
Quality decision making...
..., Strategy and Transactions, and Tax — we help our clients capitalize on transformative opportunities. We also help them fulfill regulatory requirements, keep investors informed and meet the needs of all of their stakeholders. And in a fast-changing world, we give them...
Emploi en CDI
Septembre
EY
1400 Nivelles
Il y a 2 mois
...technical support to our premarket and marketed products.
The position is located in Brussels area and is part of the global Regulatory Affairs Toxicology Group.
At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared...
À distance
...data breaches
Assist in responding to data protection-related complaints and inquiries
Provide legal support in the event of regulatory investigations or litigation related to data protection matters
Preparation of the checklist send annually and the quaterly...
Emploi contractuel
Temps complet
Travail à domicile
Director, Senior Director & Executive Director, Safety Physician SERM (Safety Evaluation & Risk Mana
...with appropriate PV experience), with additional relevant medical or scientific post-graduate qualifications.
Significant pharmacovigilance experience relating to Safety Evaluation and Risk Management, encompassing both clinical development and post-marketing activities...
...the budget for the operations department and ensure that all expenses are within budget.
Ensure compliance with all relevant regulatory requirements.
Required competencies
You have (required) :
Bachelor's degree in Business Administration, Engineering, or...
Emploi contractuel
...in release, specification and reference material for NBE.
Expertise in writing analytical documentation.
Understanding of regulatory requirements is a plus.
Very good command in French. Good command in English (ability to read scientific documents).
Are you...
...procedures and scientific reports. Significant contribution (autonomous writing and review by N+1) to and direct interactions with the Regulatory/IP teams for the preparation of the preclinical section of Regulatory/IP documents, in own area of technical expertise...
...Downstream manufacturing operations.
Compliance Teams: Work alongside compliance teams to ensure all manufacturing activities meet regulatory standards.
Corporate Quality Partners: Build trustful and Collaborative relationships with corporate quality partners,...
...Marketing – Sales – Medical Affairs) to co-develop high-quality content that aligns with the business objectives, customer needs and regulatory requirements.
Key Responsibilities:
Create, edit, and review scientific content for marketing materials and disease...
GlaxoSmithKline
1300 Wavre
il y a 2 jours
...legislation
Ensure applicable ISO requirements from a quality, safety and efficacy point of view
Acts as Person Responsible for Regulatory Compliance (PRRC) as defined by IVDR requirements
Supervise the QP for GMP/GCP/GDP compliance from a quality, safety and...
30 € par heure
...recommended processes and new technologies to the benefit of the process activities, of the MU and the whole organization.
Quality / Regulatory:
~ Ensure adherence of the technical services to legal constraints, local and international standards, cMP, Regulatory...
Pour les sous-traitants
Emploi contractuel
Pour les contractants
Dimanche
...testing and release.
· Establish and maintain robust quality control systems, procedures, and documentation in compliance with regulatory requirements.
· Draft/update/approve procedures, checklists, and batch records.
· Conduct risk assessments and root cause analyses...
BioWin
1435 Mont-Saint-Guibert
il y a 17 heures