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8 дней назад

Principal, Regulatory Science and Strategy - Real World Solutions

Формат работы
onsite
Тип работы
fulltime
Грейд
senior/director
Английский
c1
Страна
Netherlands
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Текст:
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TL;DR
Principal, Regulatory Science and Strategy - Real World Solutions (Regulatory Strategy/RWE): Leading regulatory strategy engagements and real-world evidence studies for drugs, biologics, and devices with an accent on EMA expectations, study design, and submission planning. Focus on advising regulatory pathways, shaping RWE programs across the product lifecycle, driving business development, and mentoring consulting teams.

Location: Amsterdam, Netherlands. Full-time role requiring the right to live and work in the recruiting country and willingness to travel to client locations.

Company

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

What you will do

  • Lead the sale and delivery of standalone regulatory strategy engagements, owning complex workstreams end to end.
  • Shape and deliver real-world evidence programs for regulatory audiences, including externally controlled trials, PASS, PMR/PMC fulfillment, and premarket RWE use.
  • Advise clients on regulatory pathways, EMA expectations, lifecycle management, study designs, and submission strategies, with working knowledge of FDA, MHRA, Health Canada, and PMDA.
  • Develop proposals, identify follow-on opportunities, and support business development with new and existing life sciences clients.
  • Own regulatory science delivery quality and client satisfaction while contributing to reports, presentations, and client-facing findings.
  • Provide intellectual leadership, mentor junior consultants, support recruitment, and build RSS capabilities.

Requirements

  • At least 7 years of professional experience, including substantial work in regulatory science, regulatory strategy, or product review.
  • Strong expertise in regulatory requirements and real-world study design for medical products, including EMA guidance and expectations.
  • Experience leading projects, managing multiple workstreams, developing people, and maintaining senior client relationships.
  • Strong academic background in a life science discipline or equivalent professional experience; PharmD, PhD, MD, MPH, or MS preferred.
  • Fluent English, spoken and written, is required.
  • Right to live and work in the Netherlands is required.

Nice to have

  • Prior experience at EMA or another health authority.
  • Experience in life sciences consulting or professional services.

Culture & Benefits

  • Work in a multicultural and collaborative life sciences consulting environment.
  • Participate in cross-geography engagements and interact with senior client leaders.
  • Address challenging client problems across regulatory strategy, real-world evidence, and healthcare intelligence.
  • Opportunities for intellectual leadership, capability building, and professional development.

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