Regulatory Affairs Specialist

RGF Talent Solutions Singapore Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Part time

Job summary

A leading pharmaceutical company is seeking a Regulatory Affairs Specialist to join their Singapore office. The role involves regulatory coordination, strategy development, and oversight of local affiliate regulatory activities. Strong proactive mindset, communication skills, and proficiency in Japanese are essential for this role.

Qualifications

• Minimum 2-3 years of experience in regulatory affairs, preferably in the pharma industry.
• Fluent in English and Japanese to handle regional communications.
• Proactive mindset with strong initiative.

Responsibilities

• Regulatory coordination across Asia and ASEAN countries.
• Coordinate regulatory activities including NDAs and variation filings.
• Development of regulatory strategies with cross-functional teams.

Skills

Communication

Negotiation

Problem Solving

Teamwork

Logical Thinking

Job description

Our Client: Our client is a well-established Pharmaceutical Company, headquartered in Japan. They are currently looking for a Regulatory Affairs Specialist tojoin their team in Singapore.

Proficiency in Japanese language is essential to effectively communicate with Japanese Native Stakeholders and Customers.

The Responsibilities:

• Regulatory Coordination across Asia and ASEAN countries:

• Coordinate regulatory activities including new drug applications (NDAs) and variation filings, ensuring the timely collection and submission of required documents.

• Development of Regulatory Strategies in Collaboration with Cross-Functional Teams:

• Work closely with teams such as clinical development, marketing, supply chain, and manufacturing to formulate and implement regulatory strategies for product registration and lifecycle management across the region.

• Monitoring and Tracking Regulatory Activities of Local Affiliates:

• Oversee and track the progress of regulatory submissions handled by each local affiliate.

The Requirements:

• Minimum 2–3 years of experience in regulatory affairs, preferably in the pharmaceutical or healthcare industry.

• Strong proactive mindset with a high level of initiative and ability to work independently.

• Excellent communication and negotiation skills to collaborate effectively with cross-functional teams and external stakeholders.

• Strong logical thinking and problem-solving abilities.

• Teamwork and collaboration skills, with a cooperative attitude.

• Part-time work arrangement is also possible.

• Fluent in English and Japanese to handle regional communications.

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Disclaimer: The Company complies with the Tripartite Guidelines on Fair Employment Practices (TGFEP), including the prevailing guidelines on recruitment. All qualified applicants will be considered for the position regardless of their age, race, religion, nationality, marital status, or family responsibilities. A more detailed discussion of the TGFEP is available on the Tripartite Alliance for Fair and Progressive Employment Practices (TAFEP) website at https://www.tal.sg/tafep.

JO Reference: 120651