Lead compliance oversight for the Pan European Citco entities. Build stakeholder relationships and manage compliance risks across the organization.
TK
Hybrid Regulatory Affairs Manager – Pharma
Posted 2 months ago
About the role
- Regulatory Affairs Manager focusing on innovative products and international approvals in the pharma industry. Responsible for strategic project management and regulatory activities in Stuttgart and remote.
Responsibilities
- Strategic assessment and management of new regulatory approval projects, in-licensing initiatives and innovation programs
- Independent planning and execution of regulatory activities for new marketing authorisations in the EU and other regions
- Definition of regulatory requirements in close coordination with internal regulatory teams and external partners
- Preparation, maintenance and coordination of regulatory submission dossiers, including eCTD
- Management of approval procedures as well as post-approval variations through to product launch
- Technical communication with authorities, including responding to deficiency letters
- Proactive advice to internal stakeholders on regulatory risks and strategies
- Active involvement in strategy, budgeting, compliance and process optimization
Requirements
- Degree in a scientific or medical discipline
- Several years of experience in regulatory affairs
- Practical experience in preparing and submitting regulatory dossiers
- Confident use of regulatory IT systems and eCTD
- Strong project management skills and organisational ability
- Excellent German and English language skills
Benefits
- High level of autonomy in an innovation-driven environment
- Trust-based working hours and flexible remote working arrangements (up to 60% home office)
- Customisable benefits and additional perks
- Health and wellbeing programmes
- Long-term prospects in a stable corporate environment
- Personal and professional development actively encouraged
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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