Senior/Regulatory Affairs Specialist - Europe - Home-based
Multiple Locations: Bucharest, Romania • Belgrade, Serbia • Seoul, South Korea • Warsaw, Poland • Prague, Czechia • Romania • South Korea • Hungary • Canada • Serbia • Poland • Bulgaria • Czechia • Lebanon
Requisition Number: 7237
Position Title: Senior Specialist, Regulatory Affairs
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 3,000+ professionals spans 60+ countries. We are united in cause with our customers to improve the lives of patients through new and innovative therapies.
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-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 fast-paced, deadline oriented, and changing environment
- Excellent ability to handle multiple tasks in a fast-paced and changing environment
- A minimum four-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 regulatory-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.
Employment Type: Regular
Community / Marketing Title: Senior/Regulatory Affairs Specialist - Europe - Home-based
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Bucuresti, RO