14 дней назад
Manager, Regulatory Affairs CMC (Viral Vector)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, Regulatory Affairs CMC (Viral Vector): Leading regulatory CMC activities for clinical and commercial cell therapy programs, with an accent on viral vectors, lipid nanoparticles, ATMP requirements, and high-quality regulatory documentation. Focus on developing regional strategies, assessing CMC change controls, aligning cross-functional stakeholders, and addressing complex international regulatory issues.
Location: Hoofddorp, Netherlands
Company
Develops innovative cancer immunotherapies, including CAR T-cell and T-cell receptor engineered cell therapies.
What you will do
- Lead regulatory CMC activities for assigned clinical and commercial cell therapy programs.
- Develop and execute CMC regulatory strategies aligned with product development stages, regional requirements, and program objectives.
- Author, review, and assess regulatory CMC documentation for accuracy, consistency, and compliance.
- Provide CMC guidance to cross-functional teams supporting product development, lifecycle management, and commercialization.
- Evaluate CMC change controls and determine their regulatory impact across clinical and commercial programs.
- Maintain regulatory IT systems and support health authority meeting packages, industry engagement, and task forces addressing critical CMC issues.
Requirements
- 8+ years of Regulatory Affairs or relevant industry experience after a Bachelor’s Degree.
- Relevant experience with viral vectors and/or lipid nanoparticles.
- Understanding of ICH, EMA, EU, Ph. Eur., ATMP-specific, and other regional regulatory requirements.
- Ability to drive cross-functional deliverables, influence stakeholders without direct authority, and align diverse perspectives into a coherent regulatory strategy.
- Strong written communication skills and experience drafting, reviewing, and editing regulatory, scientific, or technical documents.
- Excellent command of English, written and verbal, is required.
Nice to have
- PhD, MS, or relevant advanced certificate.
- Proficiency in Dutch.
- Experience participating in regulatory trade groups or professional associations.
Culture & Benefits
- Work in cancer immunotherapy and personalized cell therapy development.
- Collaborate across functions, sites, and international geographies.
- Operate in a fast-paced environment with changing priorities and strict timelines.
- Contribute to regulatory best-practice updates and international CMC guidance.
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 →