8 дней назад
Associate Director, Regulatory Data Management & Intelligence (Veeva Vault RIM)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Regulatory Data Management & Intelligence (Veeva Vault RIM): Defining regulatory data strategy, governance, and digital capabilities for global regulatory operations with an accent on Veeva Vault RIM, structured regulatory data, AI-enabled automation, and enterprise analytics. Focus on designing data governance frameworks, leading IDMP and xEVMPD initiatives, building migration capabilities, and maintaining compliant integrations, security, and inspection readiness.
Location: Warsaw, Poland; 70% in-office work model
Company
is a biotechnology company developing mRNA-based therapeutics and vaccines through its mRNA platform, delivery technology, and manufacturing capabilities.
What you will do
- Lead regulatory data strategy, governance, and the digital ecosystem for Regulatory Information Management.
- Own assigned Veeva Vault RIM data capabilities, including applications, registrations, submissions, regulatory objectives, health authority interactions, and structured content planning.
- Establish enterprise data standards, metadata, business rules, stewardship models, data quality practices, security, and access governance.
- Lead IDMP, xEVMPD, regulatory data migration, enterprise reporting, dashboards, and analytics initiatives.
- Define AI-enabled regulatory data management strategies using automation, advanced analytics, and emerging technologies.
- Partner with Digital, Regulatory Affairs, Regulatory Operations, CMC, Labeling, Quality, Enterprise Data, and external technology providers on requirements, integrations, releases, testing, adoption, and training.
Requirements
- Bachelor’s degree with 12+ years of relevant experience, or a master’s degree with 10+ years of relevant experience.
- Extensive experience with Veeva Vault RIM, including regulatory data objects, workflows, reporting, object security, integrations, and release management.
- Experience as a Business Capability Owner, Product Owner, Functional Lead, or equivalent leader for Veeva Vault RIM capabilities.
- Strong understanding of global regulatory submissions, registrations, regulatory master data, applications, health authority interactions, and structured regulatory data standards such as IDMP or xEVMPD.
- Experience leading enterprise governance, technology implementation, business transformation, or regulatory data migration programs.
- Proficiency in English is required for global collaboration.
Nice to have
- Advanced knowledge of Veeva Vault RIM architecture, object models, reporting, metadata, security, and release management.
- Experience with Tableau, Veeva reporting, enterprise dashboards, and analytics.
- Knowledge of APIs, middleware, enterprise integrations, and Data Lake architectures.
- Experience using AI, automation, advanced analytics, or Vibe Coding to improve regulatory processes.
- Strong stakeholder management, organizational change management, communication, and leadership skills.
Culture & Benefits
- In-person collaboration supported through a 70/30 work model.
- Competitive healthcare and voluntary benefit programs.
- Fitness, mindfulness, mental health, family-building, fertility, adoption, and surrogacy support.
- Paid vacation, bank holidays, volunteer days, sabbatical, global recharge days, and year-end shutdown.
- Savings and investment programs plus location-specific benefits.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →
Похожие вакансии
12 дней назад
Associate Director, GMP Operational Quality (Biologics)
156 600 - 234 800$
12 дней назад
Associate Director, Shift Quality Operations (Cell and Genetic Therapies)
153 900 - 230 900$
12 дней назад
Associate Director, GMP Quality CGT Personalized Medicine
148 000 - 222 000$
12 дней назад
Executive Director Quality, Cell & Gene Therapy
244 800 - 367 200$
12 дней назад
Associate Director, Manufacturing Process and Technical Quality Assurance Cell and Genetic Therapies - VCGT (Cell and Gene Therapy)
156 600 - 234 800$
10 дней назад
Director, Data Management Process, Quality & Inspection Readiness (Clinical Data Management)
183 100 - 305 200$