Therapeutic Area Expert

 
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.  Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson.  Please visit www.janssen.com for more information.
 
 Janssen, part of Johnson & Johnson Family of Companies is now looking for an experienced Therapeutic Area Expert:
 
Therapeutic Area Expert
Location: Bucharest
Full time permanent contract
 
Role Overview
The Therapeutic Area Expert will ensure the management of the allocated portfolio under supervision of Head of Regulatory Affairs Department.
 
Key responsibilities:

• Prepare documentation for submission to National Competent Authority
• Ensure full compliance with policies, procedures and validated systems
• Ensure in a timely manner, the end-to-end labelling management for allocated portfolio (relevant submissions, translations, artworks development)
• Meet the deadlines for submissions, allocated trainings and validated systems
• Main Interactions are with:
• Internal stakeholders (Marketing, Medical, Sales, Supply chain, Quality), other members of Regional Regulatory Affairs team
• National Competent Authority

• An opportunity to be part of a global market leader
• A dynamic and inspiring working environment
• Many opportunities to work on challenging projects and assignments
• Possibilities for further personal as well as professional development
• Motivating financial remuneration
• Many employee benefits

• Acquired university degree from Faculty of Pharmacy, Medicine or Biology
• Native level of Romanian, fluent level of English language (both written and spoken)
• Relevant working experience of 5-8 years in Regulatory Affairs in a multinational company.
• Proven experience in managing products approved through all type of procedures: CP, MRP/DCP, national.
• Capacity to effectively interact with National Competent Authority staff, complying with legislation and rules.
• Ability to comply with internal procedures and politics and local/European legislation.
• Ability to work independently with minimum supervision and accountable for results.
• Ability to manage multiple tasks, projects, priorities, and complex systems simultaneously.