JAPAC Regulatory Strategy Manager

One Stop Engineering; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

One Stop Engineering in Singapore is seeking a Regulatory Affairs professional to support JAPAC and Global RA in marketing authorization and lifecycle activities for assigned projects. You will interface with regulatory agencies and cross-functional teams to develop regulatory strategies and ensure timely registrations.

The role requires 5+ years of Regulatory experience and a BS in pharmacy or related field, with deep knowledge of JAPAC regulatory requirements and strong interpersonal skills.

Qualifications

• BS degree in pharmacy, pharmacology, biology or related subject.
• Minimum 5 years’ experience in Regulatory.
• In-depth knowledge of the regulatory requirements of the JAPAC region is preferred.
• Sensitivity/knowledge of JAPAC culture and ways of doing business is helpful.
• Strong interpersonal skills and proven personal development and motivational skills.

Responsibilities

• Supports JAPAC RA affiliates and Global RA in MA and lifecycle activities for assigned projects.
• Manages interface with regulatory and cross-functional stakeholders, including interaction with regulatory agencies.
• Implements regulatory strategies for assigned projects for JAPAC countries in line with area priorities.
• Partners with intercontinental commercial, market access and medical to meet business needs.
• Represents JAPAC regulatory in sub-teams to present regulatory requirements or provide input for registrations.
• Assesses scientific data for registration against JAPAC requirements, identifying gaps and mitigation strategies.
• Manages clinical trial, new drug applications and lifecycle activities to meet regulatory requirements and optimize strategies.
• Teleconferences (outside of office hours) and representation in global/area meetings.

Skills

Regulatory affairs

Stakeholder management

Regulatory strategy

Cross-functional collaboration

Strategic communication

Education

BS in pharmacy or related

Job description

One Stop Engineering in Singapore is seeking a Regulatory Affairs professional to support JAPAC and Global RA in marketing authorization and lifecycle activities for assigned projects. You will interface with regulatory agencies and cross-functional teams to develop regulatory strategies and ensure timely registrations.

The role requires 5+ years of Regulatory experience and a BS in pharmacy or related field, with deep knowledge of JAPAC regulatory requirements and strong interpersonal skills.