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5 часов назад

Regulatory Affairs Manager (Personal Healthcare)

Формат работы
onsite
Тип работы
fulltime
Грейд
middle
Английский
b2
Страна
Malaysia
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 Affairs Manager (Personal Healthcare): Managing regulatory strategy, product registrations, lifecycle activities, labeling, artwork, and promotional compliance for Malaysia and Singapore with an accent on market access, regulatory risk management, and stakeholder engagement. Focus on interpreting evolving healthcare regulations, coordinating submissions and post-approval maintenance, and translating compliance risks into practical business recommendations.

Location: Kuala Lumpur General Office, Malaysia; supporting regulatory activities across Malaysia and Singapore.

Company

hirify.global is a multinational consumer goods company with a broad portfolio of trusted personal healthcare and consumer brands.

What you will do

  • Develop and execute regulatory strategies for the Malaysia and Singapore Personal Healthcare portfolio.
  • Manage product registrations, variations, renewals, regulatory correspondence, submissions, and post-approval activities.
  • Coordinate dossier preparation, submission tracking, regulatory records, documentation, and lifecycle maintenance.
  • Review ingredient declarations, product classifications, artwork, labeling, packaging, and promotional materials for compliance.
  • Assess regulatory risks, communicate business impacts, and recommend mitigation plans to stakeholders and management.
  • Build relationships with health authorities, distributors, trade associations, and internal regional and global partners.

Requirements

  • Bachelor's degree in Pharmacy.
  • 3–5 years of Regulatory Affairs experience in pharmaceutical, consumer healthcare, personal healthcare, medical device, or another regulated industry.
  • Strong understanding of regulatory requirements in Malaysia and/or Singapore.
  • Experience applying regulations to product registration, classification, ingredients, labeling, artwork, and lifecycle management.
  • Strong analytical, problem-solving, decision-making, planning, prioritization, and execution skills.
  • Excellent written and verbal communication skills in English are required.

Nice to have

  • Experience in a multinational or regional healthcare organization.
  • Exposure to OTC products, prescription medicines, medical devices, health supplements, or related healthcare categories.
  • Familiarity with Regulatory Information Management, PASS, or similar regulatory systems.
  • Proficiency in Bahasa Malaysia.
  • Experience interacting with health authorities and managing external stakeholder relationships.

Culture & Benefits

  • Regional and global exposure within a multinational organization.
  • Meaningful responsibility and opportunities to influence business decisions from Day 1.
  • Collaboration across local, regional, and global teams.
  • Opportunities for continuous learning, knowledge sharing, and professional growth.
  • Inclusive workplace focused on ownership, innovation, leadership, and operational excellence.

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