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10 дней назад

Regulatory System Manager

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Sweden
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Regulatory System Manager (Life Sciences): Managing regulatory documentation and systems for new product development and market access with an accent on product regulations, environmental and chemistry compliance, and system integration. Focus on interpreting regulations, maintaining compliant documentation, coordinating regulatory system updates, and resolving compliance issues across projects.

Location: Uppsala, Sweden

Company

Cytiva is a hirify.global operating company developing solutions for biological research, vaccines, medicines, and cell and gene therapies.

What you will do

  • Manage regulatory documentation for new product development and market access, including safety data sheets.
  • Coordinate with IT to maintain regulatory systems and integrate them with other Cytiva systems and acquired businesses.
  • Support users in creating compliant regulatory documentation.
  • Review change requests, change orders, and regulatory updates to ensure ongoing compliance.
  • Develop pragmatic and cost-efficient solutions for regulatory issues in new product development and other projects.
  • Interpret regulations, advise on compliance impact, support investigations, and help resolve compliance questions and complaints.

Requirements

  • Bachelor’s degree in Chemistry, Biochemistry, or a related field, with several years of relevant experience.
  • Experience with product regulations, QA/RA, or other regulatory areas, or knowledge of Cytiva’s product portfolio with an interest in regulatory compliance.
  • Knowledge of environmental and chemistry regulations, including REACH, GHS labeling, and hazardous chemicals.
  • Familiarity with and interest in maintaining IT systems.
  • Ability to work with regulatory documentation, compliance requirements, and cross-functional projects.

Nice to have

  • Experience communicating with chemistry, border control, or other authorities.
  • Written and spoken Swedish.

Culture & Benefits

  • Work within the Product Regulatory Compliance department in Uppsala.
  • Collaborate with product development, IT, regulatory, and other cross-functional teams.
  • Contribute to solutions supporting life sciences, diagnostics, biotechnology, and human health.
  • Participate in a continuous improvement culture focused on practical impact.

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