regulatory affairs lead

... Infectious Disease) Ensures that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial ... point with regulatory authorities for communications relating to direct submissions of CTAs The CTA submission manager ensures that key events related to the regulatory aspects of clinical trials are tracked in the ... area (pharmaceuticals, biotechnology, biology, chemistry) Practical experience within regulatory affairs in the pharmaceutical industry in clinicaltrialssubmisions Practical experience within clinical trails area ...

For our client, a global FMCG company, we are looking for a Regulatory Affairs Specialist / Associate Manager. This regulatory position has European responsibilities for FMCG - Medical Devices for Europe. Direct Reports: None. Travel:

... servers. Load Balancers: Strong understanding of on-prem and Cloud load balancers and how they are implemented for different workloads. Automation: Ability to lead the automation of networking, including provisioning, repetitive tasks, common toil, and configuration management. Network Performance: Strong understanding of how ... and incidents. APIs: Familiarity in designing and implementing robust and maintainable APIs. Compliance: Strong knowledge of network compliance including any regulatory requirements for security and data privacy. We offer: Competitive Salary Annual performance- based bonus Additional bonuses for recognition awards Multisport ...

... risk management policies, guidelines and limits, and assists executive and business level management with minimalizing operational, market, credit legal, regulatory and other risks to the company Why this role is important to us The team you will be joining plays an important role in the overall success of the organization. ... Collaborate with Credit Approvers in supporting the business areas with guideline changes, timely analytical needs and other ad-hoc requirements. Participate in or lead a variety of departmental risk management project as assigned Oversight of the complex ERM processes followed by required analyses that may include: analyzing risk ...

... top banks work with us as we lead and serve our customers into ... our proven ability to evolve, lead, and drive new ideas at every ... join our BNY Mellon SA/NV Regulatory Reporting team. This role is ... and review of some other regulatory reporting returns at BNYM ... Level within prescribed regulatory deadlines. Work in a strong ... level. Adherence to regulatory governance policies Work with ... of the production of regulatory returns. Provide support to ... to regulatory reporting and compliance with new regulatory rules ... regulatory rules Other: Stay abreast of legislative and regulatory ... banking regulatory reporting. Local EU regulatory and ... management and / or regulatory capital knowledge Deadline ...

... and experienced Senior Project Manager to join their team. This role presents an exciting opportunity to lead the development and execution of PV, onshore wind, and BESS projects across the country. Key ... and BESS installations; collaborating with stakeholders to secure necessary permits, land rights, and regulatory approvals; conducting feasibility studies and risk assessments to evaluate project viability; developing ... projects; strong understanding of project development processes, including site selection, permitting, and regulatory compliance; excellent communication, negotiation, and interpersonal skills, with the ability to engage ...

... of the business into technical control requirements and specifications, as well as develop metrics for ongoing performance measurement and reporting. Lead the execution of security Improvement and supporting security projects that address identified risks and business security requirements. Work with your functional manager and ... agreements. Manage security issues, incidents and participate in problem and change management forums. Provide support and guidance for legal and regulatory compliance efforts, including audit support. Work with the IT architecture team to ensure that there is a convergence of business, technical and security requirements. Manage ...

Your responsibilities Lead and develop the Internal Audit Team at the Olympus Business Services in Wroclaw. Ensure that audit assignments are carried out on time and in line with regulatory requirements and internal policies and desktop procedures of Internal Audit Global. Coordinate all related activities to fulfill our J-SOX ... Statement Closing Process Controls (FSCP), Process Level Controls (PLC) and IT Governance Controls (ITGC) for Olympus in EMEA and upon request also other regions. Lead, motivate and support the team through regular communication, planning, training, coaching and performance reviews. Plans staff responsibilities in collaboration ...

... processing. Contributes to the maintenance and updating of AP processes and procedures. Delivers optimum service quality through regular contact with key stakeholders across the group. Ensures accuracy and completeness of performed AP processes by team members. Ensures that processes are carried out in line with regulatory requirements and internal accounting policies. Ensures timely and accurate processing of all AP transactions for assigned team, in accordance with performance and quality standards defined in relevant service level agreements (SLAs). Monitors, interprets, and reports team key performance indicators. Provides technical ...

... sustainable solutions that balance business, cost, risk and regulatory demands, with growth and innovation. The key goal is to support ... all aspects of technology delivery and support. The MSS IT Poland Lead role is a dual-hat role, combining all entity responsibilities for ... Impact on the Business Define, shape, communicate and lead the execution of the Nearshore Centre Strategy Ensure we have the ... & regional level forums. As needed, engage with the local regulatory bodies regarding their enquiries or assessments of Markets or ... and conduct in appropriate county-wide IT and COO forums. Lead initiatives and deliver global asset-class priorities in addition to ...

... solutions and initiatives that support company's ESG data & analytics objectives. You will lead a team of IT professionals and collaborate with various stakeholders to ensure the effective implementation ... of data governance frameworks and processes to ensure data integrity, quality, and compliance with regulatory requirements. Foster a customer-centric culture within the IT and DAO ESG delivery teams, promoting ... skills, with the ability to develop and execute an effective IT delivery strategy for ESG data initiatives. Lead a vision to design and develop software to automate the building, testing and deployment of data & ...

... stakeholders across the group. Ensures accuracy and completeness of performed AP processes by team members. Ensures that processes are carried out in line with regulatory requirements and internal accounting policies. Ensures timely and accurate processing of all AP transactions for assigned team, in accordance with performance ... high-tech products help to make peoples lives healthier, safer and more fulfilling. Headquartered in Wrocław, Olympus Business Services acts as a shared service centre for Europe, the Middle East and Africa (EMEA), thus ensuring the harmonisation of administrative processes across the region. Accounts Payable Team Lead Aplikuj

Your responsibilities Lead and develop the Internal Audit Team at the Olympus Business Services in Wroclaw. Ensure that audit assignments are carried out on time and in line with regulatory requirements and internal policies and desktop procedures of Internal Audit Global. Coordinate all related activities to fulfill our J-SOX ... Statement Closing Process Controls (FSCP), Process Level Controls (PLC) and IT Governance Controls (ITGC) for Olympus in EMEA and upon request also other regions. Lead, motivate and support the team through regular communication, planning, training, coaching and performance reviews. Plans staff responsibilities in collaboration ...

Dla międzynarodowej firmy farmaceutycznej, poszukujemy doświadczonej osoby do działu rejestracji leków. Regulatory Affairs Specialist MSN/DMR/2024/5 Zadania: Zarządzanie procesem rejestracji produktu, od oceny i przygotowania dokumentacji, po złożenie wniosku Udział w opracowywaniu i wdrażaniu strategii regulacyjnej Planowanie, zarządzanie, koordynacja i realizacja zgłoszeń regulacyjnych dla produktów w kraju i regionie Monitorowanie informacji regulacyjnych i proaktywne działanie w zakresie zidentyfikowanych zmian w wymogach regulacyjnych Ocena i wybór zewnętrznych partnerów, którzy będą pomagać w planowaniu i składaniu wniosków o rejestrację ...

... accurate and timely financial reports, including income statements, balance sheets, and cash flow statements. Ensure compliance with accounting standards, regulatory and Group requirements. Ensure the proper presentation of complex issues and transactions; Financial Planning and Analysis: Develop, implement, and manage ... especially process and tools optimization, standardization and unification, would be highly appreciated; High managerial skills, including ability to build and lead a motivated and collaborative finance team; Fluency in English (min. B2/C1 level, both oral and writing communication); Proficiency in financial software and ...