Senior Regulatory Affairs Associate – Local Regulatory Responsible Person
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Job Description
Senior Regulatory Affairs Associate focusing on local regulatory requirements and Health Authority engagements. Role involves strategic execution, compliance management, and cross-functional collaboration.
Responsibilities:
- Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities
- Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations
- Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure
- Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams
- Serve as primary interface with JAZMP (Javna agencija Republike Slovenije za zdravila in medicinske pripomočke / Agency for Medicinal Products and Medical Devices of the Republic of Slovenia), industry groups, and trade associations
- Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations
- Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
- Monitor status of submitted regulatory activities and ensure timely completion
- Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
- Ensure timely submission of renewals and mandated post-approval applications
- Maintain RIMS database with current local activity and track compliance KPIs
- Oversee compliant labelling (RCM, Folheto Informativo, packaging) including updates, translations, and promotional material review
- Act as primary RA representative for local Commercial Operations (ComOps)
- Support regional regulatory TA teams within GRA for efficient planning and submission preparation
- Collaborate with Global Labelling for Foundational Labelling Processes
Requirements:
- University degree in a life science discipline
- Minimum 5 years' experience in Slovenian Regulatory Affairs, with strong understanding of Slovenian and EU regulatory requirements
- Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
- Comprehensive lifecycle management expertise for Portuguese submissions
- Experience with JAZMP submission processes and requirements
- Competence in labelling management (updates, mock-up review, and print release processes)
- Medical device knowledge advantageous, but not essential
- Familiarity with systems such as Veeva Vault
- Excellent organizational, time management, and interpersonal skills in a global environment
- Proven ability to work effectively both independently and in teams
- Strong project management and leadership capabilities
- Expertise in influencing stakeholders and driving business-critical decisions
- Fluent in Slovenian and English (oral and written).
Benefits:
- Professional development opportunities
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