Regulatory Affairs Specialist - Contractor- Danish speaker- Remote

Stellenbeschreibung:

Overview

Join to apply for the Regulatory Affairs Specialist - Contractor- Danish speaker- Remote role at Worldwide Clinical Trials.

We’re Worldwide Clinical Trials, a global, midsize CRO with a team of over 3,500+ experts, passionate about improving lives by advancing clinical research with quality and excellence.

What You Will Do

Liaise with SAR colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis
Act as a contact point for translation review of submission documents such as application, synopsis, ICF, labels, etc.
Provide local QC of submission dossiers prior to dispatch when required
Communicate status and action plans concerning submissions to the SAR Lead and relevant project team members
Identify risks and generate mitigation strategies
Foster professional working relationships with internal and external contacts to expedite submission/approval of regulatory dossiers when possible
Maintain country-specific patient information sheets 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 requirements and maintain the regulatory intelligence database
Advise the SAR project team on appropriate regulatory strategies
Review and make recommendations on relevant documentation (e.g., labels, patient information sheets, diary cards) to comply with ICH GCP and country-specific requirements
Provide timely updates and communication of changes in the regulatory environment to the Regulatory Affairs department
Provide advice on interpretation of new legislation, guidance and directives

Your Experience

Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science
Minimum three years of experience in clinical research, 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
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

Your Skills

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
Team-oriented with a collaborative work style
Strong interpersonal skills in fast-paced, deadline-driven environments
Ability to handle multiple tasks in a dynamic environment
Proficiency in MS Office (Word, Excel, PowerPoint)

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
Team-oriented work style; collaborates effectively with others
Ability to work in a fast-paced, changing environment
Experience with contemporary digital systems

Your Experience (Continued)

Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science
Minimum three years of experience in clinical research, site activation and/or regulatory-related function within a CRO
Strong experience with Denmark regulatory processes under EU-CTR
Good knowledge of ICH GCP and country regulations
Fluency in Danish is mandatory; working knowledge of English

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.