Worldwide is seeking a Specialist, Regulatory and Site Activation to join our team. In this remote role based in Mexico, you will be responsible for driving regulatory submissions and ensuring all activities comply with ICH GCP and local requirements. You'll play a key part in our mission to make a difference for patients and their caregivers.
What You'll Do
- Liaise with colleagues to plan, organize, compile, progress, track, and submit high-quality regulatory submissions on time.
- Act as the contact point for reviewing translations of submission documents like applications, synopses, ICFs, and labels.
- Maintain country-specific patient information sheet and consent form customization text.
- Maintain country-specific drug labeling information and Country Intelligence Pages.
- Review and make recommendations on all relevant documentation to ensure compliance with ICH GCP and country-specific requirements.
What We're Looking For
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or a related science.
- Minimum two years of experience in clinical research, preferably in site activation or a regulatory function.
- Previous experience within the pharmaceutical or CRO industry.
- Thorough knowledge of ICH GCP, EU Clinical Trials Directive, and other relevant clinical research conduct guidance.
- Strong organizational, time management, planning, strategizing, and critiquing skills.
- Strong written and verbal communication skills to present information clearly in English and the local language.
- Ability to handle multiple tasks in a fast-paced, changing environment.
- Proficiency in MS Office applications including Word, Excel, and PowerPoint.
- Strong understanding of local cultural norms and healthcare systems, with the ability to build relationships with investigators and site personnel.
Nice to Have
- Multilingualism is preferred; fluency in the local language with a working knowledge of English.
Technical Stack
- MS Office applications including Microsoft Word, Excel, and PowerPoint.
Team & Environment
You will be part of the Regulatory Affairs team at Worldwide. We prioritize cultivating a diverse and inclusive environment that promotes collaboration and creativity, where people thrive by being themselves.
Work Mode
This is a fully remote position based in Mexico.
Worldwide is an equal opportunity employer committed to enabling professionals from all backgrounds to succeed. We provide equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other protected class.
