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Regulatory Affairs Specialist, фахівець з питань нормативного регулювання

  • Офіційна, біла
  • Smart Solutions , Агенція
    • VIP
  • Київ
  • Повна зайнятість·Стандартний графік: 5/2

Про вакансію

Regulatory Affairs Specialist

Location: Kyiv (Hybrid)

Contact person: IlonaKonovalova

Mob: (Telegram, WhatsApp)

E-mail: [відгукнутися]

Our client, a leading international FMCG company, is looking for a Regulatory Affairs Specialist to join its Regulatory Affairs team in Ukraine.

This role is critical for ensuring regulatory compliance and maintaining continuous market access for the company’s product portfolio in Ukraine during the ongoing alignment of Ukrainian legislation with EU requirements. The successful candidate will play a key role in regulatory compliance, innovation support, external advocacy, and cross-functional collaboration.

Key Responsibilities

Regulatory Compliance

  • Ensure full compliance of product portfolios with Ukrainian and EU regulatory requirements.
  • Monitor legislative and regulatory changes and assess their impact on products, processes, and business activities.
  • Prepare, maintain, and coordinate local compliance documentation.
  • Manage product registrations and notifications, including submission of regulatory dossiers.
  • Communicate with regulatory authorities and support inspections, audits, and compliance-related inquiries.
  • Support issue management and resolution of regulatory challenges.

Innovation & Product Development Support

  • Conduct regulatory assessments for new products and innovation projects.
  • Provide regulatory guidance on formulations, labeling, and product claims.
  • Support product launches by ensuring regulatory readiness and compliance.

Advocacy & External Engagement

  • Represent the company in trade associations, industry working groups, and discussions with regulatory authorities.
  • Support local advocacy activities and contribute to regulatory developments relevant to business objectives.
  • Interpret new legislation and communicate regulatory implications to business stakeholders and cross-functional teams.

Compliance Project Management

  • Lead and coordinate local regulatory compliance projects.
  • Collaborate closely with R&D, Marketing, Supply Chain, Legal, and other business functions.
  • Ensure timely implementation of regulatory changes and business continuity.

Requirements

  • Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Biotechnology, Regulatory Affairs, or a related field.
  • 2−4 years of experience in Regulatory Affairs within cosmetics, detergents, chemicals, FMCG, healthcare, or pharmaceutical industries.
  • Strong understanding of Ukrainian and EU regulatory frameworks.
  • Practical experience with product notifications, registrations, compliance documentation, and regulatory submissions.
  • Experience interpreting legislation and translating regulatory requirements into business actions.
  • Strong project management and stakeholder management skills.
  • Excellent communication and presentation skills.
  • Advanced Microsoft Office skills.
  • Fluent English and Ukrainian, both written and spoken.
  • Ability to work effectively in a fast-changing regulatory environment.

Will Be a Strong Advantage

  • Experience with EU Cosmetics Regulation (CPR).
  • Knowledge of CLP and REACH regulations.
  • Experience representing a company before authorities, industry associations, or regulatory working groups.
  • Experience supporting product innovation and product launches in regulated industries.

What the Company Offers

  • Opportunity to work for a leading global FMCG company with internationally recognized brands.
  • Competitive salary package.
  • Official employment according to Ukrainian labor legislation.
  • Annual performance bonus.
  • Medical and life insurance.
  • Hybrid working model.
  • Modern office in Kyiv with backup power and connectivity solutions.
  • Extensive learning and development opportunities.
  • Wellness benefits and employee product discounts.
  • International environment and collaboration with global teams.

If you have experience in Regulatory Affairs and would like to contribute to regulatory compliance, innovation, and regulatory strategy within a global business, we would be pleased to hear from you.


Ключові вимоги і навички

  • Англійська — середній, українська — середній
  • Досвід роботи від 2 років.
  • Вища освіта.
  • Комунікабельність
  • Відповідальність
  • Regulatory Affairs
  • Регуляторна відповідність продукції
  • Реєстрація та нотифікація продукції
  • Підготовка тендерної документації
  • Знання законодавства України та ЄС
  • Аналіз регуляторних змін
  • Оцінка відповідності продукції
  • Підтримка запуску нових продуктів
  • Маркування та продуктові твердження
  • Робота з державними регуляторними органами
  • Управління будівельними проєктами
  • Lobbying та галузеві асоціації
  • Compliance Management
  • Cosmetics Regulation (CPR)
  • REACH
  • CLP
  • FMCG напрямок
  • Косметична галузь
  • Побутова хімія
  • Фармацевтична галузь
  • Product Registration
  • Project management
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