Pfizer Regulatory Affairs Officer in Budapest, Hungary
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talents who share our core values and mission of making the world a healthier place.
For our Pfizer office in Budapest, Hungary we are looking for a
Regulatory Affairs Officer (CTA specialist)
This is what you can look forward to:
Management of Clinical Trial Applications (CTAs) Regulatory activities
Liaise with clinical research project managers to seek to understand clinical research program.
Accountable for the regulatory compliance within CTA responsibilities
Preparation of Marketing Authorization (MA) applications, renewals, variations and related activities
Link with the Product Quality Manager for timely implementation of the approved labelling-associated artworks
Handling with all relevant global databases and systems and other applications, as appropriate
Keep updated the local registration tracking of all new/ongoing applications, renewals and variations
Provide accurate, consistent, timely and balanced responses to the Regulatory inquiries
Acquire quality processes and procedures knowledge.
Apply a risk management approach
Provide support for all audits under Medical Director / Platform Head
What you offer:
Life science, medical science, pharmaceutical or chemistry university degree
2 years' work experience in Regulatory Affairs/CTA or related function within pharmaceutical sector
Understanding of National, EU and ICH directives and regulations
Knowledge of national/European Union Regulatory and Clinical Trials legislation and guidelines for CTA and MAA
Demonstrates keen analytical skills and attention to detail
Ability to work independently as well as part of a team
Strong project management skills, problem solving, communication and interpersonal skills
High level of proficiency in both local language and English (written and spoken)
Very good time management
In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture and unparalleled career development opportunities.
Please apply in English documents only!
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.