Regulatory Affairs Manager
hace 2 meses
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.
The Regulatory Affairs Manager is responsible for preparing high-quality and timely regulatory applications and notifications to Spain Health Authorities, coordinating activities with Regulatory Affairs, Sr. Associates and acting as a key contact within Spain, the Senior Manager Italy & Iberia and the regional regulatory RA organizations. Working in collaboration with Global Regulatory Affairs, and country/cluster Regulatory Affairs they will provide comprehensive regulatory management of Medical Devices for Surgical and Vision Care. This position is based in Cornellà de Llobregat. In this role, a typical day will include:
Providing oversight of regulatory submissions to assure technical accuracy and completeness.
Providing regulatory support for company compliance initiatives, including SOP development.
Providing responses to regulatory agencies regarding product information or other topics.
Maintaining knowledge of pertinent regulations and guidance and escalation, if applicable.
Keeping abreast of current regulatory requirements and provide regulatory advice
Coordinating responses to requests for information from regulatory authorities
Leading the management of promotional material approvals and of localized product labeling
demonstrating good organizational and time management skills, including the ability to work on multiple projects and adherence to timelines.
Identifying and implementing opportunities to improve efficiency of RA processes and systems whilst not compromising on regulatory compliance.
Ensuringall documents submitted to regulatory agencies are complete, well organized, in regulatory compliance, and presented in a manner that facilitates agency review.
Being responsible for maintaining records of regulatory submissions and communications with relevant regulatory agencies.
Providing assessments of changing regulations and guidance, and identifyinhany needed changes to internal policies and processes.
WE ARE SEEKING:
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 (procedures with medicines registered by national, Mutual Recognition and Centralized procedures).
Demonstrated ability to lead and work effectively with multiple stakeholders – internal and external and excellent communication
Strong initiation and organizational skills
HOW YOU CAN THRIVE AT ALCON:
Comprehensive benefits package
Training and continuous development; Be part of a high performing leader in ophthalmology company with a lot of opportunities to further develop your professional career.
International exposure
Open, friendly and collaborative culture; Work in a challenging environment with an outstanding team that will support him to achieve goals and performance.
Hybrid model
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