Regulatory & Site Activation Specialist at Worldwide Clinical Trials, Apply Now!
Are you passionate about regulatory compliance and clinical research? Join Worldwide Clinical Trials, a globally respected mid-sized CRO, as a Specialist in Regulatory and Site Activation. This is a home-based opportunity in India for experienced clinical research professionals who want to make a meaningful impact in drug development and patient care.
- Job Role: Specialist, Regulatory and Site Activation – Contractor- India- Home-Based
- Location: Virtual India (Remote)
- Job requisition ID: JR100870
About The Company:
We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers, and doers, and together, we are changing the way the world experiences CROs – in the best possible way.
Why Worldwide:
Everyone plays an important role in making a difference for patients and their caregivers. Join us to be part of a diverse and inclusive environment that promotes 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.What the Regulatory Affairs Department Does at Worldwide:
Our Regulatory Affairs team holds extensive industry experience in shaping project plans to meet diverse regulatory requirements. Our experts strategize the most efficient route for our clients’ products and provide guidance to ensure continual regulatory compliance.
What You Will Do:
- Liaise with SAR colleagues
- Drive plan, organize, compile, progress, track, and submit regulatory submissions
- Act as a contact point for translation review
- Maintain country-specific patient information sheet and consent form
- Review and make recommendations on all relevant documentation
What You Will Bring to the Role:
- Organizational and time management skills
- Aptitude for planning, strategizing, managing, monitoring, and scheduling
- Strong written and verbal communication skills
- Strong ability to handle multiple tasks in a fast-paced environment
Your Experience:
- A minimum four-year college curriculum with a significant concentration in medical, biological, physical, health, pharmacy, or other related sciences
- Minimum two 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, EU Clinical Trials Directive, and other relevant guidance on conducting clinical research.
- 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.
For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.
Keywords: regulatory specialist, site activation, clinical research, CRO, regulatory affairs, remote job, India, contractor.
