Drug Regulatory Affaires Manager

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.