Job Purpose
To support the Regulatory Affairs function by ensuring compliance with Spanish and European pharmaceutical regulations, maintaining product registrations, preparing regulatory documentation, and supporting lifecycle management activities for prescription medicines, generics, and OTC products.
Key Responsibilities
Regulatory Submissions & Maintenance
- Prepare, compile, review, and submit regulatory dossiers to Spanish and European health authorities.
- Support lifecycle maintenance activities for registered medicinal products.
- Manage variations, renewals, notifications, and regulatory updates.
- Track submission timelines and regulatory commitments.
Regulatory Compliance
- Ensure compliance with applicable Spanish and EU pharmaceutical regulations.
- Monitor changes in regulatory requirements and communicate impacts to stakeholders.
- Maintain regulatory documentation in accordance with company procedures and health authority requirements.
Product Lifecycle Management
- Support product registrations from development through commercialization.
- Coordinate labeling updates and packaging changes.
- Assist with regulatory strategy implementation for existing and new products.
Cross-Functional Collaboration
- Work closely with Quality, Pharmacovigilance, Supply Chain, Medical Affairs, and Commercial teams.
- Support responses to health authority queries and deficiency letters.
- Participate in internal project meetings and provide regulatory guidance.
Pharmacovigilance & Market Access Support
- Maintain awareness of pharmacovigilance obligations and reporting requirements.
- Support activities requiring coordination between Regulatory Affairs and Pharmacovigilance functions.
- Provide regulatory input for market access and reimbursement initiatives where required.
Documentation & Systems
- Maintain regulatory databases and product records.
- Ensure accurate archiving and document control.
- Generate regulatory status reports and metrics.
Required Qu
📌 Regulatory Affairs Manager (Madrid)
🏢 Cipla
📍 Madrid