Regulatory Affairs Specialist - Contractor- Danish speaker- Remote

Overview

Regulatory Affairs Specialist – Contractor- Danish speaker- Remote. Worldwide Clinical Trials is a global midsize CRO with a mission to improve lives by driving innovative regulatory solutions for diverse clinical trials. We value passion, purpose and collaboration in a diverse and inclusive environment.

What You Will Do

• Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis
• May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
• Where required provide local QC of submission dossiers prior to dispatch
• Effectively communicate to the SAR Lead and relevant project team members the status and action plans concerning submissions
• Identify risks and generate mitigation strategies
• When possible, foster professional working relationships with internal and external contacts to ensure expeditious submission/approval of regulatory dossiers
• Maintain country specific patient information sheet and consent form customization text
• Maintain country specific drug labeling information
• Maintain Country Intelligence Pages
• Be familiar with and comply with SOPs, ICH GCP and applicable regulations
• Stay informed of changing regulatory legislative requirements and maintain regulatory intelligence database
• Advise the SAR 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
• Provide timely and relevant updates and communication of changes in the regulatory environment to the Regulatory Affairs department
• Provide advice to the Regulatory Affairs department on interpretation of new legislation, guidance and directives

What You Will Bring To The Role

• Strong organizational and management skills
• Strong planning, strategizing, managing, monitoring, scheduling, and critiquing 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
• Proficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPoint
• Aptitude for contemporary digital systems is helpful

Your Experience

• Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science
• Minimum three year of experience in clinical research, in site activation and/or regulatory-related function within a CRO
• Candidates must have strong experience in the regulatory process in Denmark, specifically under the EU-CTR, to be considered for this role.
• Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations
• Fluency in the Danish language is a mandatory requirement; 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 Discover a world of difference at Worldwide! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.