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1 месяц назад

Associate Regulatory Affairs Director (Europe SME)

Формат работы
onsite
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
Romania
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
Associate Regulatory Affairs Director (Europe SME) (European Regulatory Affairs): Leading complex European regulatory activities across product lifecycles and advising pharmaceutical and biotechnology clients with an accent on market applications, lifecycle management, post-marketing submissions, and European regulatory procedures. Focus on managing regulatory programmes, developing client strategies, leading regulatory professionals, and driving proposal and business growth initiatives.

Location: Bucharest, Romania

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.

What you will do

  • Lead complex European regulatory activities across market applications, lifecycle management, and post-marketing submissions.
  • Provide strategic guidance on Centralised, Decentralised, Mutual Recognition, and National procedures.
  • Advise clients on regulatory strategy, governance, and decision-making.
  • Contribute to proposal development, bid defense meetings, and business growth initiatives.
  • Lead, coach, and develop Regulatory Affairs professionals in a global matrix environment.
  • Support resource planning, forecasting, operational excellence, and continuous improvement.

Requirements

  • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or a related discipline.
  • Extensive Regulatory Affairs experience and strong knowledge of European regulatory requirements and submission pathways.
  • Significant people management and leadership experience.
  • Experience with marketed products, post-marketing activities, and lifecycle management.
  • Proven ability to manage complex regulatory programmes and stakeholder relationships.
  • Strong communication, presentation, influencing, and commercial skills.

Nice to have

  • Experience with biologic products.
  • CRO, consultancy, or client-facing Regulatory Affairs experience.
  • Experience with proposal development or bid defense activities.

Culture & Benefits

  • Work with a global team of regulatory experts supporting healthcare innovation.
  • Opportunity to build and lead high-performing teams.
  • Broad exposure to regulatory strategy, commercial partnership, and leadership.
  • Potential progression into broader Global Regulatory Affairs leadership positions.

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