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Senior Regulatory Affairs Officer - Job Opportunity at Aspen Pharma Group

Dublin, Ireland
Full-time
Senior
Posted: January 28, 2025
On-site
EUR 75,000 - 95,000 per year based on Dublin market rates for senior regulatory affairs positions

Benefits

Pharmaceutical industry career development opportunities
Global exposure through international regulatory work
Professional development and training programs
Team-based collaborative environment
Healthcare industry expertise development

Key Responsibilities

Lead regulatory strategy development and implementation for pharmaceutical products
Manage complex international regulatory submissions and health authority interactions
Coordinate cross-functional teams for product registrations and maintenance
Oversee dossier preparation and submission processes
Direct regulatory compliance and documentation management
Drive product lifecycle management from a regulatory perspective

Requirements

Education

Life sciences (BSc in Chemistry/Biology, etc.) or pharmacy degree; Master's Degree + Doctorate Degree/Multiple Masters

Experience

4-5 years experience in a Regulatory Affairs environment and pharmaceutical industry

Required Skills

Detailed knowledge of EU and other regions current registration requirements Solid knowledge of specific national requirements in EU and other regions IT Skills Knowledge of IT tools specific for RA and pharmaceutical sector (eCTD, databases, change control management)
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Sauge AI Market Intelligence

Industry Trends

Increasing complexity in global regulatory frameworks is driving demand for experienced RA professionals Growth in pharmaceutical industry digitalization is requiring enhanced technical expertise in eCTD and regulatory information systems Rising focus on accelerated approval pathways and innovative therapies is creating new regulatory challenges

Role Significance

Typically part of a 10-15 person regulatory affairs department with matrix reporting to global regulatory teams
Senior position with strategic input into regulatory planning and substantial autonomy in managing international submissions

Key Projects

Marketing Authorization Applications for new products Complex variation management across multiple territories Health Authority interactions and strategic regulatory planning Cross-functional regulatory support for product lifecycle management

Success Factors

Deep understanding of evolving regulatory landscapes across multiple jurisdictions Strong project management capabilities for handling multiple concurrent submissions Excellent stakeholder management skills for coordinating with internal teams and health authorities Strategic thinking ability to anticipate and address regulatory challenges

Market Demand

High demand with growing need for regulatory expertise in post-Brexit European pharmaceutical landscape

Important Skills

Critical Skills

EU regulatory framework expertise - essential for managing European submissions eCTD technical knowledge - crucial for modern regulatory submissions Strategic assessment capabilities - vital for regulatory planning

Beneficial Skills

Additional regional regulatory knowledge Change management expertise Leadership and mentoring abilities

Unique Aspects

Extensive involvement in global regulatory strategy
Opportunity to work with diverse product portfolio
Strong focus on professional development and regulatory expertise building

Career Growth

2-4 years in current role before progression to management position

Potential Next Roles

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

Company Overview

Aspen Pharma Group

Aspen Pharma Group is a multinational pharmaceutical company with a strong focus on both branded and generic medications

Major player in global pharmaceutical manufacturing and distribution with significant presence in emerging markets
Strategic European regulatory hub in Dublin supporting global operations
Professional corporate environment with emphasis on regulatory excellence and global collaboration
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