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Regulatory Affairs Consultant

Regulatory Affairs Consultant

HiRO - Harvest Integrated Research OrganizationMalaysia, Malaysia
2 days ago
Job description

Overview

Are you looking to grow your career in Regulatory Affairs and make an impact in the development of new medicines? We’re seeking a Regulatory Affairs Consultant to support global and local regulatory projects, providing scientific and strategic input throughout the product development lifecycle. This role offers an exciting opportunity to work closely with experienced consultants, clients, and project teams—developing hands-on expertise in regulatory submissions, strategy, and client communication.

What You’ll Do

  • Support and coordinate regulatory consulting projects, including CTD authoring, document preparation, country submissions, gap analysis, and regulatory strategy.
  • Collaborate with senior consultants to provide high-quality regulatory insights and ensure projects are delivered on time and meet client expectations.
  • Conduct research and apply relevant guidelines (ICH and local regulations) to support client projects.
  • Participate in client discussions, project scoping, and proposal preparation.
  • Contribute to continuous improvement of tools and processes that enhance project quality and efficiency.
  • Learn from and be mentored by senior regulatory professionals to develop your consulting and project management skills.

What You’ll Bring

  • 2–6 years of experience in Regulatory Affairs, the pharmaceutical industry, or clinical research.
  • Strong understanding of ICH guidelines and local regulatory requirements.
  • Excellent communication, organisation, and problem-solving skills.
  • Ability to work effectively in a cross-functional and multicultural team environment.
  • Bachelor’s degree or above in life sciences, pharmacy, medicine, or a related field (e.g., pharmacology, molecular biology, chemical engineering).
  • Pharmacist licence preferred.
  • Bilingual proficiency in English and Chinese (written and spoken) highly desirable.
  • Why Join Us

    You’ll join our brand new office in Malaysia and be part of a supportive and collaborative global team, working on diverse projects that shape the future of drug development and healthcare. We offer opportunities for professional growth, mentorship, and ongoing development within an international regulatory environment.

    Apply

    Apply today to take the next step in your Regulatory Affairs career and help bring innovative therapies to patients worldwide.

    Seniority level

  • Associate
  • Employment type

  • Full-time
  • Job function

  • Project Management and Research
  • Industries

  • Biotechnology Research and Research Services
  • #J-18808-Ljbffr

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    Consultant • Malaysia, Malaysia

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