Regulatory & Site Activation Specialist

Regulatory & Site Activation Specialist - Taiwan- Remote

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 submission documents such as applications, synopses, ICFs, labels, etc.

• 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 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 in English and local language both

• 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.

Your experience

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences

• Minimum three years 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, and other relevant guidance on conducting clinical research.

• Experience in regulatory submissions in Taiwan

• Multilingualism preferred; 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.