Regulatory Affairs Assistant

AITBIOTECH PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading biotechnology firm in Singapore is seeking a regulatory affairs professional to manage document control processes and assist in product registrations. The ideal candidate will have a bachelor's degree in a relevant science field, alongside strong language skills in English and Chinese for communication with partners, ensuring compliance with various regulatory standards.

Qualifications

• Bachelor’s degree in a relevant field.
• Proficiency in Chinese for regulatory translation.
• Excellent communication skills in English.

Responsibilities

• Manage document control process for Quality Management Systems.
• Prepare documents for submissions to health authorities for product registration.
• Assist sales team with regulatory discussions.

Skills

Attention to detail

Problem-solving

Interpersonal skills

Analytical skills

Fluency in Chinese

Fluent English

Education

Bachelor’s degree in Biotechnology, Biomedical Sciences, Life Sciences, or Biochemistry

Tools

Microsoft Office

Job description

Job Description:

• Manage document control process for Quality Management Systems in compliance with ISO13485, GDPMDS and any other standards as appropriate
• Assists in meeting the company’s objectives and sales goals by your effort in implementing smooth workflows and processes to have a highly efficient and functional sales support operation
• Develop and maintain standard operating procedures and working practices
• Prepare supporting documents for submissions to local and/or overseas health authorities for new product registration
• Responsible for regulatory and product licensing-related activities.
• Support (internal & external) audits to ensure that regulatory and quality requirements have been met
• Assist sales team in discussion with clients on regulatory matters
• Ability to manage multiple simultaneous activities in a rapidly changing environment
• Such other responsibilities as required and instructed by your superior and the management

Job Requirement:

• Bachelor’s degree preferably in Biotechnology, Biomedical Sciences, Life Sciences, or Biochemistry.
• Translator for chinese regulatory related document.
• Proficiency in Chinese is a must for communication with our Chinese partners.
• Fluent English; excellent written and verbal communication skills.
• Proficient in Microsoft Office
• Good interpersonal skills to work with colleagues and team members, and advise others on compliance and regulatory matters
• Excellent analytical skills, attention to detail
• Pro-active and problem-solving attitude
• Highly autonomous, yet with a profound team spirit