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Regulatory Program Director - Job Opportunity at Roche

Basel, Switzerland
Full-time
Senior
Posted: May 21, 2025
On-site
CHF 160,000 - 220,000 per year based on Swiss market rates for senior regulatory positions

Benefits

Comprehensive healthcare package aligned with industry-leading standards
Professional development and career advancement opportunities
Global exposure and international project involvement
Work-life balance initiatives
Collaborative and inclusive work environment

Key Responsibilities

Lead global technical regulatory strategy development for biologics and pharmaceutical products
Drive regulatory submissions and health authority interactions worldwide
Oversee CMC regulatory documentation and compliance standards
Direct cross-functional teams for product lifecycle management
Manage regulatory risk assessment and mitigation strategies

Requirements

Education

Master's degree in scientific field (advanced degrees preferred)

Experience

Extensive experience in CMC regulatory affairs

Required Skills

Global regulatory strategy expertise Technical regulatory knowledge for biologics Cross-functional team leadership Project management Digital transformation capabilities Data analysis and interpretation Problem-solving and innovation mindset
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Industry Trends

Increasing complexity in biological drug development requiring sophisticated regulatory expertise Growing focus on expedited regulatory pathways and breakthrough designations Rising importance of digital transformation in regulatory processes Shift towards harmonized global regulatory frameworks

Role Significance

Typically leads a team of 5-8 regulatory professionals while coordinating with larger cross-functional groups of 20-30 members
Senior leadership position with significant influence on global product strategy and regulatory success

Key Projects

Global regulatory strategy development for novel biologics Major market authorization applications Post-approval change management Health authority negotiations and submissions Process optimization initiatives

Success Factors

Deep understanding of global regulatory landscapes and ability to anticipate regulatory challenges Strong strategic thinking and risk assessment capabilities Excellence in stakeholder management and communication Ability to balance innovation with compliance requirements

Market Demand

High demand with growing need for biologics expertise and regulatory professionals who can navigate complex global requirements

Important Skills

Critical Skills

Technical regulatory expertise in biologics development Strategic thinking and lifecycle management Cross-functional leadership and stakeholder management Digital literacy and data management capabilities

Beneficial Skills

Experience with synthetic molecules Knowledge of combination products Change management expertise Innovation methodology

Unique Aspects

Rare opportunity to work with both biologics and synthetic molecules
Strong focus on digital transformation in regulatory processes
Global reach with significant impact on healthcare accessibility

Career Growth

3-5 years in role before advancement to executive positions

Potential Next Roles

Global Head of Regulatory Affairs VP of Regulatory Strategy Chief Regulatory Officer

Company Overview

Roche

Global healthcare leader with significant presence in both pharmaceuticals and diagnostics, known for innovation in biotechnology

Among top 3 pharmaceutical companies globally with strong focus on personalized healthcare
Major strategic hub in Basel with significant influence on European operations
Innovation-driven environment with strong emphasis on scientific excellence and regulatory compliance
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