Ir à oferta completa

REGULATORY AFFAIRS MANAGER - RUSSIAN SPEAKER

Descrição da oferta de emprego

IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics, and human ingenuity to drive healthcare forward.
To our lifecycle management team we are looking for Regulatory Affairs Manager that will support activities on Russian market.
This is an individual contributor role that requires native/fluent Russian language knowledge and solid experience in post approval regulatory affairs in Russia.
Main Responsibilities Acts as a Regulatory Lead on complex projects, which may include technical writing or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate.
Competently writes regulatory and technical documents with minimal review by senior staff.
Establishes relationships with customers and stakeholders; may meet face to face without rest of team to discuss regulatory issues and present lessons learned.
Adopts a proactive and flexible approach to resolve any issues.
Undertakes detailed review and management of budgets related to projects, including out of scope activities.
Ensures revenue is recognized and challenges when appropriate.
May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development.
May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff.
May write new regulatory standard operating procedures, and propose revisions or act as reviewer for regulatory standard operating procedures.
Manages meetings with Regulatory Agencies.
Qualifications Bachelor's or Master's Degree Degree in Life Science or related discipline At least 8 years relevant experience in lifecycle management regulatory affairs for Russian market Native (preferred) or fluent in Russian language Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate.
Expert in planning and delivering work on time keeping quality parameter in mind.
In depth knowledge of regulatory procedures and intelligence in Russia Ability to work closely with client regional heads to determine the Regulatory, Publishing & submission strategy and execute project plan.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Strong software and computer skills, including Microsoft Office, publishing applications and tools, as applicable.
Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, CMC and publishing projects.
Project leadership experience.
Ability to adapt quickly to a rapidly changing environment.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
Learn more at https://jobs.
qvia.
om IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare – and human health – forward.
Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore new possibilities.
No matter your role, everyone at IQVIA contributes to our shared goal of improving human health.
Thank you for your interest in growing your career with us.
Ir à oferta completa

Detalhes da oferta

Empresa
  • QBG Quintiles Bulgaria
Localidade
  • Em todo Portugal
Endereço
  • Indeterminado - Indeterminado
Tipo de Contrato
  • Indeterminado
Data de publicação
  • 25/10/2024
Data de expiração
  • 23/01/2025
SPA MANAGER
Casa Deitada - Turismo Açores Lda

Oferta de posição como spa manager procura-se spa manager para ser terapeuta e spa manager em boutique hotel de luxo na ilha de são miguel, açores, portugal... requisitos do trabalho requisitos: - experiência como spa manager - terapeuta com versatilidade em vários tipos de massagens (clássicas e exóticas)......

Estágio iefp: oportunidade business manager
Outglocal

Requisitos do trabalho perfil pretendido dos candidatos: capacidade de relacionamento interpessoal licenciatura em marketing ou comunicação empresarial, apto para medida estágio ativar capacidade de comunicação para falar com diferentes públicos compreender as expectativas dos potenciais clientes resiliência......

Project manager (mercado imobiliário de luxo)
Buyme property

A buyme property, empresa em expansão e de excelência a celebrar 25 anos de sucesso no mercado imobiliário algarvio, com escritórios em vilamoura, quarteira, almancil e faro, seleciona para buyme prestige, projeto no mercado imobiliário de luxo: project manager... responsabilidades: gestão 360º do projeto......

Sales manager (m/f/d)- the editory collection hotels
The editory collection hotels

Estamos a reforçar o departamento de vendas, com a função de sales manager (m/f/d): principais funções:• promover as unidades hoteleiras nos potenciais mercados nacionais e internacionais; • manutenção da carteira de clientes e angariação de potenciais novos clientes; • prospeção de mercado nacional......

Customer service representative( italian speaker)
Cluster osl

Requisitos do trabalho fluent italian speaker... salary paid in twelve or fourteen months... 2023 salary: up to 1,200€ monthly gross (excluding performance bonus and/or other benefits)... ambitious to engage with other team members and share experiences... job types: full-time, permanent (probation......

Marketing Manager
Do iT Lean

Cv's not submitted in english will not be considered... as a marketing manager, you will be responsible for managing activities to build awareness and demand generation and for coordinating a wide range of marketing activities: events, database marketing, digital marketing activities......

Reservations Manager
InterContinental Hotel

We are hiring a reservations manager who will work in our customer service and accept reservations for clients... monitor billing arrangements... manage inventories for hotel rooms... computer skillsorganizationcommunication skillsmultitaskstrong leadership skillspositive mentalitygood teamwork skills......

Business Manager Coimbra
AtenaT

D2destás interessada/o? envie já o teu cv com a referência ''job business manager - coimbra'' ---------> *****@*****... procuramos pessoas que tenham muita ou pouca experiência profissional, o que importa é ter von-tade de aprender e não ter medo de desafios!a equipa prime da vodafone está a recrutar......

Store Manager (M/F) Aeroporto de Faro
Get The Job

Desafio: atualmente, encontramo-nos a recrutar um(a) luxury store manager para uma marca conceituada dentro do segmento de acessórios de luxo - óculos de sol... principais responsabilidades: -gerir o plano de atividade da loja; -alcançar os objetivos definidos, previamente, pela empresa; -capacidade......

Customer service representative ( german speaker)
Cluster osl

Requisitos do trabalho excellent communication skills and ability to work well in a team... ✓customer satisfaction orientation and proactivity... ✓team building activities organized by cluster and/or its team members... ✓positive attitude and willingness to perform additional tasks......