Regulatory Affairs Specialist

Trades Workforce Solutions; Singapore; Hybrid; SGD 60,000 - 80,000; Part time

Job summary

A leading regulatory service provider in Singapore is seeking a Regulatory Affairs Specialist to manage regulatory documents and ensure compliance within the pharmaceutical industry. The ideal candidate has a Bachelor's degree in Life Sciences and at least 1 year of experience in regulatory affairs. Responsibilities include coordinating submissions, monitoring regulations, and providing training. The role offers flexible hours and a competitive salary package of up to $3,500.

Qualifications

• Minimum 1 year of experience in regulatory affairs in healthcare or pharmaceuticals.
• Good knowledge of relevant regulatory requirements (e.g., FDA, EMA, ISO).
• Strong understanding of risk management principles.

Responsibilities

• Prepare regulatory documents for approvals.
• Monitor changes in regulations for compliance.
• Develop regulatory strategies with product teams.
• Maintain regulatory files for different markets.
• Conduct training on regulatory requirements.
• Act as a contact for regulatory authority queries.

Skills

Regulatory submission software

Analytical skills

Communication

Project management tools

Education

Bachelor's degree in Life Sciences or related field

Certification in Regulatory Affairs (e.g., RAC)

Job description

Job Description

Industry / Organization Type: Pharmaceutical Co

Position Title: Regulatory Affairs Specialist

Working Location: Islandwide (Hybrid)

Working Hours: Flexi-Hours

Salary Package: Basic up to $3,500

Duration: Permanent/Part-Time

Key Responsibilities

• Prepare and submit regulatory documents, including pre‑market submissions, to authorities to obtain required approvals.
• Monitor and review changes in regulations and industry standards, and provide recommendations to maintain compliance.
• Work with product development, quality assurance, and marketing teams to develop regulatory strategies that support business plans.
• Assist in preparing and maintaining regulatory files and product registrations for different markets.
• Conduct training for internal teams on regulatory requirements and compliance procedures.
• Act as the main contact for regulatory authority queries and manage communication between authorities and internal stakeholders.

Qualifications

• Bachelor's degree in Life Sciences, Regulatory Affairs or a related field.
• Minimum 1 year of experience in regulatory affairs in the healthcare or pharmaceutical sector.
• Good knowledge of relevant regulatory requirements and guidelines (e.g., FDA, EMA, ISO).
• Strong analytical skills with the ability to understand and interpret complex regulatory documents and data.
• Certification in Regulatory Affairs (e.g., RAC) is an advantage.
• Proficient in regulatory submission software and electronic document management systems.
• Strong understanding of risk management principles and methods.
• Familiar with project management tools and techniques to support timely regulatory submissions.

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