Regulatory Affairs Senior Specialist: Expanding Asia Pacific Market Expert
7 days ago
Persolkelly Singapore Pte Ltd is seeking a highly skilled Regulatory Affairs Senior Specialist to join our team in expanding our presence in the Asia Pacific market. As a key member of our regulatory affairs team, you will be responsible for leading projects related to product registrations and renewals, ensuring compliance with local regulations, and maintaining organized filing and documentation processes.
About the Role
We are looking for an experienced Regulatory Affairs professional with a strong track record of success in the medical device or diagnostic industry, particularly in South-East Asia or the Asia-Pacific region. Your expertise in regulatory compliance, labeling, and product development will be invaluable in helping us achieve our business objectives. You will also have excellent communication and interpersonal skills, enabling you to collaborate effectively with cross-functional teams and external customers. Additionally, your ability to work independently, prioritize tasks, and manage multiple projects simultaneously will be essential in meeting deadlines and achieving results.
Key Responsibilities
The successful candidate will be responsible for:
- Liaising with global cross-functional teams and external customers to maintain strong relationships and address submission queries;
- Preparing and reviewing labels and submission documents to ensure compliance with local regulations and guidelines;
- Maintaining organized filing and documentation processes in line with company standards;
- Tracking, managing, and reporting on regulatory project timelines and identifying project risks for escalation when necessary;
- Collaborating extensively with global cross-functional teams and external customers to maintain strong communicative relationships;
- Acting as an in-country representative and subject matter expert, providing insights on new or updated regulations and guidelines;
Requirements
To be considered for this role, you must possess:
- A Bachelor's degree and/or above in Life Sciences or related fields;
- At least 3 years of direct regulatory experience in the medical device or diagnostic industry, supporting at least 1 or more South-East Asia country or within Asia-Pacific region;
- Excellent written and communication skills, and the ability to work in a dynamic multi-functional environment;
- Well-versed in MS Office applications.
Compensation and Benefits
This full-time position offers a competitive salary package of SGD $4,500++ per month, reflecting the estimated salary range for this role based on the location and industry standards. The package includes benefits that support your well-being, career growth, and financial security. We also offer opportunities for professional development, mentorship, and networking within the organization.
About Persolkelly Singapore Pte Ltd
Persolkelly Singapore Pte Ltd is a leading recruitment agency specializing in staffing solutions for various industries, including healthcare, finance, and technology. Our team of experts has extensive knowledge of the job market and can provide valuable insights to help you navigate your career journey.
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