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Manager/Sr Manager, Regulatory Affairs CMC - Job Opportunity at Gilead Sciences

Singapore, Singapore
Full-time
Senior
Posted: April 24, 2025
On-site
SGD 180,000 - 250,000 annually based on Singapore biotech market rates and role seniority

Benefits

Comprehensive healthcare coverage typical of large biotech firms
Professional development opportunities in global regulatory affairs
International exposure and cross-functional collaboration opportunities
Career advancement within global pharmaceutical organization

Key Responsibilities

Lead CMC regulatory strategy development and execution for Australia/New Zealand markets
Manage health authority interactions and negotiations for product approvals
Drive cross-functional collaboration with global teams for regulatory submissions
Ensure compliance with ICH and regional regulatory requirements
Author and coordinate complex regulatory documentation
Provide strategic input for global filing strategies

Requirements

Education

Bachelor of Science (8 years experience) or Master of Science (6 years experience)

Experience

6-8 years depending on education level

Required Skills

Strategic regulatory planning and execution CMC regulatory documentation authoring Risk assessment and mitigation Cross-functional collaboration Cultural awareness and communication Project management Health authority interaction Regulatory intelligence
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Sauge AI Market Intelligence

Industry Trends

Increasing complexity in CMC regulations globally requiring specialized expertise Growing focus on regulatory harmonization across Asia-Pacific markets Rising demand for professionals with combined technical and regulatory expertise Trend toward risk-based approaches in regulatory submissions

Role Significance

Typically part of a 10-15 person regional regulatory affairs team, collaborating with global teams of 50+ professionals
Senior strategic position with significant influence on product approval timelines and market access

Key Projects

Marketing authorization applications for novel therapeutics Post-approval variation management Regulatory strategy development for product lifecycle Health authority negotiations and resolution of complex regulatory challenges

Success Factors

Deep understanding of both technical CMC aspects and regulatory landscape Ability to navigate cultural nuances in regulatory interactions Strong project management skills with multiple concurrent submissions Strategic thinking balanced with practical execution capabilities

Market Demand

High demand due to expansion of pharmaceutical companies in Asia-Pacific region and increasing regulatory complexity

Important Skills

Critical Skills

CMC regulatory expertise specifically for Australia/New Zealand markets Strategic thinking and risk assessment capabilities Cross-cultural communication and negotiation skills

Beneficial Skills

Experience with biologics and drug-device combinations Knowledge of multiple regulatory frameworks beyond ICH Change management expertise

Unique Aspects

Rare opportunity to influence regulatory strategy in key growth markets
Combination of technical CMC expertise with regulatory affairs
Global exposure with regional authority focus

Career Growth

2-4 years in role before advancement opportunity, depending on performance and business growth

Potential Next Roles

Director of Regulatory Affairs Head of Regional Regulatory Affairs Global Regulatory Strategy Lead

Company Overview

Gilead Sciences

Leading biopharmaceutical company with strong focus on viral diseases and oncology

Top-tier global pharmaceutical company with significant market presence and extensive product portfolio
Strategic Asia-Pacific hub role supporting regional expansion initiatives
Matrix organization emphasizing global collaboration and innovation-driven approach
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