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MAH Regulatory Affairs Expert (Market Authorization) - Remote, Japan

Morunda

Role overview

Qualifications

  • Extensive experience in regulatory affairs
  • Strong written and verbal communication skills
  • Broad understanding of pharmaceutical manufacturing, pharmacovigilance, and quality assurance
  • Creative and solution-oriented approach to problem solving

Responsibilities

  • Act as the General Marketing Supervisor (GMS), overseeing Quality Assurance and Pharmacovigilance functions
  • Develop and implement regulatory strategies for assigned pharmaceutical products
  • Lead the preparation and submission of regulatory documentation
  • Ensure uninterrupted product supply and proactively identify regulatory risks

Key facts

  • Remote from: Japan
  • Full time
  • Regulatory Affairs Manager
  • Japanese

Hard skills

Other skills

  • Quality Assurance
  • Communication
  • Problem Solving

About the company

Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC) logo

Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)

  • Staffing & Recruiting
  • TPE
  • 11–50
➡️ HERE IS WHAT WE DO We specialize in searching for and recruiting top talent in the Pharmaceutical and Medical Device Industry in Japan (JPAC) and Asia (APAC) via our Japan and Singapore offices. ➡️ HOW DO WE GET THINGS DONE With nearly two decades of recruitment experience in the Pharmaceutical Industry in Japan and Asia, we have the client-relationship expertise, knowledge, persistence, dedication, and diligence to ensure even the most challenging recruitment searches are successful. ➡️ FOR HIRING MANAGERS Through our extensive contacts with the best, brightest, and most well-prepared candidates in the market, combined with the ability to fully understand our clients' needs, we can quickly provide the perfect solution to your requirements. ➡️ FOR JOB SEEKERS We take the time to listen, understand and present opportunities to you when you are ready. ➡️ WHERE HAVE YOU SEEN US Since 2006, Philip has been writing a monthly column for Pharma Japan. He has also been published in Life Science Leader, The Fordyce Letter and Biosimilar Development. ➡️ WHAT OTHERS SAY "Philip has exceptional knowledge of the Japanese Pharmaceutical Industry. Philip is also dedicated to advancing global business leaders’ knowledge and applied skills through his insightful articles. I have found the articles beneficial in both the business environment and as excellent discussion topics as part of the International Management course I teach at the University of Texas. I highly recommend Philip to support a company's efforts to advance their firm with a "Global Mindset" staff and practices". Scott Manning, Lecturer at San Diego State University and former Country Manager of Alcon Japan "Philip is extremely knowledgeable of the Japanese Pharma Industry and his articles are always very intriguing. He is certainly a person that can identify talent and professionals that could grow and add value to the hiring company" Masaki Nakanishi, Director of Business Development at AnGes, Inc.
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Job description

Roles and Responsibilities

  • Act as the General Marketing Supervisor (GMS), overseeing Quality Assurance and Pharmacovigilance functions and reporting to the legal representative. Manage both pre- and post-approval GMS responsibilities with effectiveness and accountability.

  • Develop and implement regulatory strategies for assigned pharmaceutical products, executing activities independently in compliance with Japanese regulations, guidance, and established procedures.

  • Lead the preparation and submission of regulatory documentation, including Module 1 and Application Forms for Marketing (AFM), provide regulatory intelligence, liaise with local health authorities (PMDA and MHLW), support NHI price listing, and define overall regulatory strategies.

Typical Accountabilities

  • Serve as GMS for assigned products, with full accountability for achieving regulatory milestones across the entire product lifecycle and for all categories of medicinal products.

  • Apply in-depth regulatory expertise to support approvals and ensure uninterrupted product supply, proactively identifying regulatory risks and developing appropriate mitigation strategies.



Requirements

  • Extensive experience in regulatory affairs, with the ability to evaluate complex scientific critically and technical data to assess regulatory suitability and ensure clear, well-supported regulatory justifications.
  • Strong written and verbal communication skills, with the ability to convey issues clearly, concisely, and logically; excellent listening and stakeholder engagement capabilities.
  • Broad understanding of related disciplines such as pharmaceutical manufacturing, pharmacovigilance, and quality assurance, combined with a creative and solution-oriented approach to problem solving.



Company Overview

A global regulatory and compliance solutions provider, primarily focused on the life sciences and healthcare industries. The company offers a broad range of services, including regulatory affairs, product registration, market access, and other services that help pharmaceutical, biotechnology, medical device, and consumer health companies navigate complex regulatory frameworks and ensure compliance with local and international regulations.

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