Posao Regulatory

 ...We are seeking a Senior Regulatory Affairs Associate to join a dedicated client project supporting the implementation of approved labelling content into compliant packaging and artwork materials for pharmaceutical products. You will work closely with Regulatory Affairs, Labelling... 

 ...regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members. Prepare site regulatory documents, reviewing for completeness and accuracy. Ensure accurate completion and maintenance of internal systems, databases and... 

 ...Ergomed seeks a Manager for Study Start-Up and Regulatory Affairs in Belgrade to lead clinical trial initiation activities and regulatory strategy across medium-to-high complexity projects. The role combines hands-on project delivery with strategic guidance, business development... 

 ...cares about the people behind the work as much as the work itself, we would love to hear from you. The Manager, Study Start Up and Regulatory Affairs is responsible for developing the strategy based on regulatory requirements and for coordinating and overseeing all SSU deliverables... 

 ...Senior Pharmacovigilance Specialist role focused on managing safety submissions, regulatory intelligence, and pharmacovigilance systems. The position involves overseeing ICSR submissions, periodic safety reporting, regulatory compliance activities, and system testing across... 

 ...rare diseases and oncology, in addition to working across other therapeutic areas. As our company continues we grow we are seeking a Regulatory and Start Up Specialist to join our growing team. Essential functions of the job include but are not limited to: Responsible for... 

 ...of development and a broad range of therapeutic areas, gaining valuable experience in diverse and dynamic research environments. Regulatory and Start-Up Specialist At IQVIA, our Study Start Up Specialists play a critical role in bringing clinical trials to life. Working... 

 ...Thermo Fisher Scientific seeks a Regulatory Affairs Manager to lead global clinical trial regulatory submissions and strategy across multiple Phase 1–4 projects. This senior individual contributor role involves client engagement, project oversight, financial management, and... 

 ...commercialization of innovative therapies that improve patient outcomes worldwide. We are seeking an experienced Associate Program Director, Regulatory Affairs to join our Global Regulatory Affairs team in Eastern Europe. In this strategic client-facing role, you will lead complex... 

 ...Global Regulatory Affairs CMC Specialist Place of work: Belgrade/Vrsac About the job: The CMC Global Specialist is responsible for preparing, maintaining, and coordinating high-quality regulatory CMC documentation in accordance with global regulatory requirements... 

 ...ProPharma seeks a regulatory affairs and pharmacovigilance specialist for Central and Eastern European operations. The role encompasses preparing marketing authorization applications, conducting safety monitoring, managing adverse event reporting, and ensuring compliance with... 

 ...changing lives, and bringing new medicines to those who need them.  Job Description Join our international team and support regulatory safety reporting aspects of clinical research projects, streamlining communication, maintaining electronic systems and managing... 

CMC globalni specijalista Mesto rada: Beograd/Vršac O poslu: Gobalni specijalista za globalne regulatorne poslove – CMC odgovoran je za pripremu, održavanje i koordinaciju visokokvalitetne regulatorne CMC dokumentacije u skladu sa globalnim regulatornim zahtevima....

 ...compliance and auditability Knowledge of how online casino and sportsbook products operate across different jurisdictions, including regulatory requirements, reporting obligations, player limits, self-exclusion, verification flows and compliance-driven product constraints,... 

 ...seeks a Safety Scientist II/III to manage drug safety profiles in clinical trials, conduct signal detection activities, and oversee regulatory reporting across varying complexity levels. The remote role involves mentoring junior staff, leading smaller projects, and collaborating... 

 ...•    Opportunity to expand your knowledge in areas of financial risk statistical models, risk management, financial management, and regulatory landscape by resolving challenges that our clients are facing. •    Getting to know best practices applied in banks and other financial... 

 ...• May perform pre-inspection visits at sites, host audits/inspections; ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections, as assigned. Qualifications • The right candidate must be Certified... 

 ...visualization tools such as Power BI or Tableau Exposure to cloud data platforms — Snowflake, Databricks, or similar Knowledge of regulatory frameworks relevant to data (GDPR, BCBS 239, or sector-specific) Your future role As a Data Governance Technology (Senior)... 

 ...In this role, you'll combine clinical leadership with scientific expertise to ensure the highest standards of patient safety and regulatory compliance. You'll be at the forefront of complex safety decision-making and partnering with cross-functional teams and our client to... 

 ...accordance with established processes Ensures quality and adherence to the relevant policies, SOPs, and working instructions, GCP and regulatory guidelines. Establishes clear communication lines and escalation pathways, communicates with project stakeholders Provides... 

 ...governance across the clinical development portfolio. Partnering with Clinical Operations, Vendor Management, Therapeutic Strategy, Regulatory, Quality, and Finance teams, this role drives vendor selection, strategic partnerships, and outsourcing excellence to support successful... 

 ...pharmaceuticals across immunology, gastroenterology, and dermatology to healthcare professionals while maintaining compliance with regulatory standards. Responsibilities Promote assigned specialty medicines according to approved brand strategy and local regulations... 

 ...European operations. This role supports a multi-entity AI GPU infrastructure business operating across jurisdictions with differing regulatory, employment, and corporate governance requirements. The ideal candidate is dual-qualified or has demonstrated working knowledge of both... 

 ...cloud resources, including identity management, network security, and data security. Support compliance with industry standards and regulatory requirements. Collaboration and Support: Work closely with development, operations, QA, and security teams to align cloud... 

 ...review of safety documentation, including narratives, aggregate reports, annual and periodic safety reports, risk management plans, regulatory submissions, labeling, protocols, investigator brochures, and case report forms. Support safety governance activities, including... 

 ...sometimes incomplete. You’ll help clarify what’s needed and translate it into practical engineering work. Adapting the system to regulatory updates . As the EU releases new FAQs or adjustments, you will help interpret their implications and adapt parts of the system to remain... 

 ...direct Central Monitoring experience Working knowledge of the clinical drug development process, including ICH, GCP guidelines, and regulatory requirements Knowledge and experience with clinical databases, electronic data capture systems, quality control processes, and... 

 ...advanced education combined with experience. ~ Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. ICH GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. ~ Broad protocol... 

 ...platforms. Experience in fintech, financial services, or payments, particularly regarding transaction, reconciliation, settlement, or regulatory reporting data. Experience with sensitive or regulated data and an understanding of data privacy and governance (e.g., GDPR).... 

 ...thousands of end customers through simple APIs and webhooks. Our goal is very high rates of automated approval, without compromising on regulatory standards in the EU, UK and US. Key Areas of Responsibilities: Collaborate closely with our product team to ensure efficient...