Drug Regulatory Affaires Manager
Budapest, Magyarország Legal
Job description
Job facts
Regulatory Affairs Manager
An innovative multinational pharmaceutical company is looking for a Regulatory Affairs Manager
Position summary :
The positon holder will be responsible for full scope of Regulatory Affairs tasks regarding his/her assigned products and clinical trials, supporting business activities and interaction externally with Health Authority and internally with global and local functions.
Responsibilities :
All activities regarding regulatory processes
· Centralized, DCP/MRP and national procedures
· Product Life Cycle management, variations, renewals, most common task is the preparation and coordination of translations of documentations
· Performing Artwork change management and development processes
· Managing clinical trial submissions, amendments
· Tracking regulatory data and archiving documents
· Knowledge of current national and EU regulations
Business support activities
· Providing regulatory information to Medical, Sales and Marketing functions regarding assigned products
· Liaisoning with Medical, Market Access, Quality Assurance, Marketing, Logistics and Finance
· Supporting new product launch activities
· Regulatory Intelligence
· Ensuring compliance to all relevant global or local policies and procedures
Skills and competencies :
· University degree in Pharmacy, Medical, Biology or Natural Sciences
· 3-years regulatory experience in pharmaceutical industry, experience with regulatory submissions
· Fluent English both in written and spoken language
· Native Hungarian language
· Computer skills (MS Office)
· Good analytical skills, result oriented, accurate and reliable, open personality, good communications skills, good team worker
• Experience with clinical trial regulatory activities and drug safety is an advantage
Compensation :
· Market competitive salary, Cafeteria
· Who we are
At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer.