Senior/Regulatory Affairs Specialist - Europe - Home-based Bucharest

Senior/Regulatory Affairs Specialist - Europe - Home-based
Bucureşti
Bucharest, Bucharest, Romania

Job Details

Who we are



Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases, is applied to develop flexible plans and solve problems quickly for our customers.



Our talented team of 3, + professionals spans + countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.



Why Worldwide



We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our
- on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!



What you will do

Liaise with colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis. Where required provide local QC of submission dossiers prior to dispatch

May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.

Effectively communicate to the Lead and relevant project team members the status and action plans concerning submissions and advise the project team about appropriate regulatory strategies

Review and make recommendations on all relevant documentation e. g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements

What you will bring to the role

Strong organizational and management skills

Self-motivated learning about current regulatory processes and intelligence

Excellent written and verbal communication skills to clearly and concisely present information

Team-oriented work style; seeks and gives guidance to others

Strong interpersonal skills in a
- paced, deadline oriented, and changing environment

Excellent ability to handle multiple tasks in a
- paced and changing environment

Your background

A minimum
- year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science

Minimum two years of experience in clinical research, in
- related function

Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance

Multilingualism preferred; fluent in local language; working knowledge of English

We love knowing that someone is going to have a better life because of the work we do.



To view our other roles, check out our careers page at ! For more information on Worldwide, visit or connect with us on.