Regulatory Affair (Executive / Senior Executive / AM)

Regulatory Affairs (Executive / Senior Executive / AM)

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.

Q&A

What to expect in this role :

• Expected monthly basic salary.
• How many years of Regulatory Affairs experience do you have?
• Which languages are you fluent in?
• Notice period required at current employer?

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