Regulatory Affairs Manager – Pharmaceuticals
TRIGA Consulting GmbH & Co. KG
full-time
Posted on:
Location Type: Hybrid
Location: Stuttgart • Germany
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About the role
- 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 authorizations in the EU and other regions
- Defining regulatory requirements in close coordination with internal regulatory teams and external partners
- Preparation, maintenance and coordination of regulatory dossiers, including eCTD
- Management of approval procedures as well as post-approval variations up to product launch
- Professional communication with regulatory authorities, including responses to deficiency letters
- Proactive advising of internal stakeholders on regulatory risks and strategies
- Active participation in strategy development, 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
- Proficiency with regulatory IT systems and eCTD
- Strong project management skills and organizational ability
- Excellent German and English language skills
Benefits
- High level of autonomy in an innovation-oriented environment
- Trust-based working hours and flexible remote-working arrangements (up to 60% home office)
- Customizable benefits and additional perks
- Health and wellbeing programs
- Long-term prospects within a stable corporate environment
- Personal and professional development actively encouraged
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsregulatory activitiesregulatory dossierseCTDmarketing authorizationsapproval procedurespost-approval variationsregulatory IT systemsproject managementbudgeting
Soft Skills
professional communicationorganizational abilitystrategic assessmentproactive advisingprocess optimization
Certifications
degree in scientific disciplinedegree in medical discipline