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Regulatory Affairs Manager - Job Opportunity at EirGen Pharma

Waterford, Ireland
Full-time
Senior
Posted: January 17, 2025
On-site
EUR 90,000 - 120,000 per year based on Irish pharmaceutical industry standards and senior management level

Benefits

Competitive salary package positioning against pharmaceutical industry standards
Career progression opportunities with continuing education support
High-performance culture development programs
Comprehensive benefits aligned with pharmaceutical industry standards

Key Responsibilities

Lead global regulatory strategy development for Oral Solid Dose product pipeline
Drive cross-functional collaboration for regulatory dossier preparation and health authority interactions
Manage CMC regulatory compliance and risk assessment processes
Oversee regulatory team development and succession planning
Direct quality control for submission documentation and correspondence
Guide manufacturing change assessments and technical risk evaluations
Develop and maintain regulatory best practices and procedures

Requirements

Education

Primary degree in scientific/life science discipline, advanced degree preferred (PhD, MS, PharmD)

Experience

Senior level regulatory affairs experience with management background

Required Skills

Global CMC regulations expertise IND, IMPD, BLA & MAA filing experience Cross-functional leadership Strategic planning Influence and relationship building Problem solving Continuous improvement mindset Customer focus
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Industry Trends

Increasing regulatory complexity in global pharmaceutical markets requiring sophisticated CMC expertise Growing focus on accelerated approval pathways demanding agile regulatory strategies Rising importance of regulatory intelligence in early-stage development planning

Role Significance

Likely managing a team of 3-5 regulatory professionals based on company size and portfolio scope
Senior management position with strategic influence on product development and market access

Key Projects

Global regulatory strategy development for new product launches Health authority negotiations and submissions Cross-functional regulatory compliance initiatives Team development and regulatory excellence programs

Success Factors

Deep understanding of evolving global regulatory landscape Strong strategic planning and risk assessment capabilities Excellence in stakeholder management across cultural boundaries Ability to translate complex regulatory requirements into actionable business strategies

Market Demand

High demand position due to expanding global regulatory requirements and shortage of experienced regulatory professionals

Important Skills

Critical Skills

Global regulatory strategy development - Essential for market access and product success CMC technical expertise - Critical for product development and compliance Cross-functional leadership - Key for coordinating complex regulatory projects

Beneficial Skills

Digital submission systems expertise Change management capabilities Quality management systems knowledge

Unique Aspects

Combination of established pharmaceutical operations with startup-like culture
Focus on rapid product development and market access
Strong emphasis on employee development and career progression

Career Growth

2-4 years in role before advancement, depending on business growth and portfolio expansion

Potential Next Roles

Senior Director of Regulatory Affairs Head of Regulatory Affairs VP of Regulatory Affairs and Quality

Company Overview

EirGen Pharma

Mid-sized pharmaceutical company focused on rapid product development and market expansion

Growing presence in global pharmaceutical market with strong focus on oral solid dose formulations
Strategic European location with global market access capabilities
Dynamic, growth-oriented environment maintaining small-company agility with increasing global reach
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