11,000 associates are working in Global Drug Development at Novartis.
Would you like to be part of our dynamic Regulatory Affairs team?
You will be responsible for the execution of all regulatory tasks for your allocated products with the purpose to ensure rapid regulatory approvals and maintenance on the market, all with focus on supporting and driving the local business in line with global regulatory affairs (RA) and Country Organization (CO) plans. Your regulatory expertise ensures fast market access with the best possible label.
• Builds and maintains excellent relationship with competent regulatory authorities and internal stakeholders.
• Performs all submissions and approvals for medicinal products according to the timetable given by the HQ and according to the CO plan. Maintains full responsibility of all regulatory activities on assigned projects and prioritizes activities to ensure completion of goals. Works to minimize regulatory issues and helps prevent unnecessary delays.
• Supports local RA Head in monitoring the whole regulatory approval process identifying critical steps and suggesting optimization actions.
• Responds to technical and scientific HA questions. Coordinates, timely submits and follows-up response documents to HA requests.
• Maintains all RA related databases and information systems in line with internal policies and SOPs.
• Participates in the processes for the preparation of packaging materials and implementation of all artwork changes in line with internal policies and SOPs.
• Monitors regulatory environment and timely provides regulatory competitive intelligence including generics.
• Provides regulatory input to reimbursement applications.
• Reviews promotional and educational materials for compliance with legislation and internal rules.
What you'll bring to the role
• University Degree in science related field
• Fluency in Dutch, French and English
• A minimum of 3 years experience in regulatory affairs, dealing with regulatory authorities.
• Excellent knowledge of EU, Belgian & Luxembourgian pharmaceutical regulations and legislation.
• Good communication, organization and negotiation skills.
• Dynamic, entrepreneurial and high self-motivated personality.
• Excellent administrative management skills.
• Cross functional team player
• Very detail oriented and analytical skills.
• Able to work with strict deadlines.
• Result driven mindset (excellent problem solving & project management skills).
• Manage workload and unpredictable issues, requiring organizational skills.
• Sense of effective organization (helicopter view) and initiative (proactive & autonomous attitude).
• Pragmatic and business sense.
• IT skills, particularly in relation to using databases.
Why consider Novartis?
750 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
Global Drug Development
REG AFFAIRS GDD
Company / Legal Entity
NOV PHA BEL
Research & Development