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Regulatory Affairs Specialist
hace 1 mes
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
Key Responsibilities- Provide oversight of regulatory submissions to ensure technical accuracy and completeness.
- Support company compliance initiatives, including SOP development.
- Respond to regulatory agencies regarding product information or other topics.
- Maintain knowledge of pertinent regulations and guidance.
- Keep abreast of current regulatory requirements and provide regulatory advice.
- Coordinate responses to requests for information from regulatory authorities.
- Lead the management of promotional material approvals and localized product labeling.
- Demonstrate good organizational and time management skills.
- Identify and implement opportunities to improve efficiency of RA processes and systems.
- Ensure all documents submitted to regulatory agencies are complete, well organized, and in regulatory compliance.
- Be responsible for maintaining records of regulatory submissions and communications with relevant regulatory agencies.
- Provide assessments of changing regulations and identify needed changes to internal policies and processes.
- Bachelor's degree in health sciences, preferably in Pharmacy.
- Master's Degree in Pharmaceutical Industry is an asset.
- Spanish, and English proficiency. Catalan is highly valuable.
- Knowledge of European and Spanish regulations on medicines and medical devices.
- Experience in Regulatory Affairs of Medicines and Medical Devices of at least 5 years.
- Demonstrated ability to lead and work effectively with multiple stakeholders.
- Strong initiation and organizational skills.
- Comprehensive benefits package.
- Training and continuous development.
- International exposure.
- Open, friendly, and collaborative culture.
- Hybrid model.
