Regulatory Affair

2 weeks ago

KL Eco Kuala Lumpur, Malaysia PCCS Group Berhad Full time 60,000 - 120,000 per year
Job Description
  • Execute and oversee regulatory submissions to ensure timely processing and compliance.
  • Maintain proactive communication and good working relationships with regulatory authorities.
  • Prepare, review, and maintain regulatory documentation and product registration files.
  • Assist in the development, implementation, and maintenance of SOPs and other regulatory documents.
  • Review promotional and marketing materials to ensure compliance with applicable regulations and company guidelines.
  • Support regulatory strategy planning and contribute to continuous improvement initiatives.
  • Maintain Good Distribution Practice for Medical Devices (GDPMD) compliance and support ISO-related activities.
  • Participate and assist during internal and external audits when required.
  • Execute day-to-day regulatory activities, monitor submission progress, and update relevant stakeholders.
  • Support training sessions and presentations for internal and external meetings related to regulatory topics.
  • Collaborate cross-functionally with other departments to ensure alignment with regulatory requirements.
  • Ensure proper documentation, tracking, and archiving of regulatory submissions and correspondence.
Requirements
  • Bachelor's Degree in Biomedical Science, Life Sciences, Pharmacy, or a related field.
  • Minimum 1–3 years of experience in regulatory affairs within the medical device or pharmaceutical industry.
  • Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
  • Good oral and written communication skills in English (additional languages an advantage).
  • Strong analytical and problem-solving skills; able to think critically and resolve issues independently.
  • Result-oriented, reliable, and able to perform well under pressure.
  • Independent yet a strong team player with a continuous improvement mindset.
  • Trustworthy, resourceful, and demonstrates initiative in completing tasks.
  • Willing to learn and adhere to company processes and regulatory requirements.
  • Able to conduct or assist in training and presentations for internal/external stakeholders.
  • Mandarin speaking required as need to liaise with Mandarin speaking business partner.
Remark

Candidates with more extensive regulatory experience (typically 5 years or more) and proven leadership capabilities may be considered for the Assistant Manager (Regulatory Affairs) position, with expanded responsibilities in strategy development, team supervision, and regulatory project leadership.

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