Regulatory Affairs Specialist - Belgium/Netherlands- Home-Based
Multiple Locations: Brussels, Belgium • Belgium • Netherlands
Requisition Number: 7280
Position Title: Regulatory Affairs Specialist
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 the Regulatory Affairs Specialist does at Worldwide
Be a subject matter expert and primary contact for activities supporting Regulatory Authority submissions in coordination with Site Activation & Regulatory (SAR) colleagues for awarded projects. Responsible for leading the planning, initiating, and tracking documents required for regulatory submissions and communicating status, risks and actions related to project regulatory activities. May act in a support role to local CRA with regulatory activities when a dedicated regulatory resource is not present locally. Reports to the Site Activation and Regulatory Lead.
What you will do
- Liaise with SAR colleagues to drive plan, organize, compile, progress, track and submit regulatory submissions on a timely basis and with a consistently high level of quality.
- May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
- Maintain country specific patient information sheet and consent form customization text.
- Maintain country specific drug labeling information.
- Maintain Country Intelligence Pages.
- 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
- Organizational and time management skills
- Aptitude for planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
- Strong written and verbal communication skills to clearly and concisely present information.
- Strong ability to handle multiple tasks in a fast-paced and changing environment.
- Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint
- Strong understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel.
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science
- Minimum three year of experience in clinical research, preferably in site activation and/or regulatory-related function
- Previous experience within the pharmaceutical/CRO industry.
- Thorough 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: Regulatory Affairs Specialist - Belgium/Netherlands- 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: Amsterdam, Noord-Holland NL