Regulatory Affairs Manager

2 days ago

Kuala Lumpur, Kuala Lumpur, Malaysia Solution Group Berhad Full time 120,000 - 240,000 per year
Key Responsibilities:

Regulatory Strategy & Lifecycle Management

  • Optimise regulatory strategies for new product registrations and changes to existing products.
  • Manage the lifecycle of the existing product portfolio, ensuring timely renewals and updates.
  • Coordinate and participate in the preparation of regulatory submissions to competent authorities.

Compliance & Documentation

  • Prepare and submit technical dossiers (ICH/CTD, ACTD format) and technical files to regulatory authorities.
  • Ensure proper compilation and submission of documents to NPRA, including responses to queries during NDA evaluations.
  • Maintain accurate reporting and ensure full compliance with regulatory requirements.
  • Review and approve product labelling for compliance with regional regulations.

Stakeholder Engagement

  • Collaborate cross-functionally with R&D, Production, and QA departments.
  • Build and maintain credible relationships with national health authorities and external partners.
  • Provide regulatory insights and updates to internal teams on changes impacting operations.

Scientific & Technical Oversight

  • Review scientific data to ensure completeness, accuracy, and alignment with program goals.
  • Stay up to date and act as a subject matter expert on local, ASEAN, ICH, and WHO regulatory requirements.

Operational Oversight

  • Lead regulatory risk assessments and mitigation planning.
  • Maintain regulatory databases and ensure accurate tracking of submission status and approvals.
  • Respond to ad-hoc regulatory requests and provide timely updates to senior management.

Pharmacovigilance & Safety

  • Support pharmacovigilance activities by managing drug safety documentation (e.g. RMP) and adverse reaction data.
  • Conduct safety trend analysis and maintain global safety databases.
  • Deliver safety training and assist in compliance and QA activities as needed.

Licensing & Certification

  • Ensure validity of all licenses including company, product, and GMP certifications for external partners
Qualifications & Skills:
  • Candidate must possess of Bachelor's Degree of Pharmacy, Science, Biotechnology or equivalent
  • Licensed pharmacist with Pharmacy board of Malaysia
  • Experience in Regulatory Affairs with strong track records, product registrations and life cycle management. Quality assurance experience would be an advantage
  • An established candidate with a minimum of 5 years of experience in the Pharmaceutical industry
  • Outstanding strategic planning with the ability to develop actionable solutions and recommend strategies
  • Have fluent oral and written communication skills in English
  • Distinct opportunity to build and be involved in the growth and evolution of the company
  • Promising opportunity to advance in an international company
  • Willing to work beyond office hours when needs arise

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