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Regulatory and Start Up Specialist - Job Opportunity at Precision for Medicine

Singapore, Singapore
Full-time
Mid-level
Posted: May 12, 2025
Hybrid
SGD 65,000 - 85,000 annually based on Singapore market rates for similar regulatory specialist roles in clinical research

Benefits

Innovative research environment
Professional development opportunities
Contribution to groundbreaking cancer therapies
Global exposure in clinical research

Key Responsibilities

Lead clinical trial application process and submission preparation
Manage regulatory submissions and authority interactions
Coordinate site activation and essential document collection
Drive compliance with international and local regulations
Facilitate cross-functional communication for project deliverables

Requirements

Education

Bachelor's degree in life sciences or related field, or Registered Nurse (RN)

Experience

1 year or more as a Regulatory or SU specialist

Required Skills

Strong communication and organizational skills Experience with computerized information systems Electronic spreadsheets proficiency Word processing competency Electronic mail proficiency Fluency in English

Certifications

RAC certification (preferred) Advanced degree (MD/PhD/PharmD) preferred
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Sauge AI Market Intelligence

Industry Trends

The clinical research industry is experiencing rapid growth in Asia-Pacific, with Singapore establishing itself as a key hub for clinical trials and regulatory operations. Increasing demand for specialists who can navigate complex regulatory frameworks across multiple jurisdictions, particularly in emerging markets. Growing focus on precision medicine and rare disease research is creating specialized roles requiring deep regulatory expertise combined with scientific knowledge.

Role Significance

Typically part of a 5-8 person regulatory affairs team, collaborating with larger cross-functional clinical operations group of 20-30 members
Mid-level position with significant operational responsibility and potential for strategic input in clinical trial processes

Key Projects

Multi-center clinical trial regulatory submissions Site activation and compliance programs Cross-border regulatory coordination initiatives Process standardization and optimization projects

Success Factors

Deep understanding of ICH-GCP guidelines and local regulatory frameworks Strong project management capabilities with ability to handle multiple submissions simultaneously Excellence in stakeholder management across multiple cultures and jurisdictions Attention to detail while maintaining strategic overview of trial requirements

Market Demand

High demand with significant growth potential due to increasing clinical trial activity in APAC region and Singapore's position as a biomedical hub

Important Skills

Critical Skills

Regulatory framework expertise across multiple jurisdictions Project management capabilities in clinical trial context Stakeholder management across cultural boundaries Technical documentation and submission management

Beneficial Skills

Data analytics understanding Experience with innovative trial designs Knowledge of precision medicine landscape Understanding of biomarker development and validation

Unique Aspects

Specialized focus on precision medicine and rare diseases sets this role apart from traditional CRO regulatory positions
Opportunity to work with cutting-edge therapies and novel trial designs
Strong emphasis on data analytics integration with regulatory processes

Career Growth

2-3 years in current role before advancement, with potential fast-track progression based on performance and market demand

Potential Next Roles

Senior Regulatory Affairs Manager Clinical Operations Manager Regulatory Strategy Lead Regional Regulatory Affairs Director

Company Overview

Precision for Medicine

Precision for Medicine is a specialized CRO focused on precision medicine, particularly in rare diseases and oncology, positioning itself at the intersection of clinical research and advanced analytics

Growing mid-size CRO with strong specialty focus, competing effectively against larger generalist CROs through specialized expertise
Strategic expansion in Asia-Pacific with Singapore serving as key regional hub for clinical operations
Fast-paced, innovative environment with strong emphasis on scientific expertise and cross-functional collaboration
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