Specialist, Regulatory & Site Activation

Worldwide; India; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Worldwide Clinical Trials seeks a Subject Matter Expert for regulatory submissions, site activation, and maintenance across awarded projects. You will plan, initiate, and track essential documents, ensuring country/site requirements support activation goals and communicating risks and actions to the RAM.

You will be the primary regulatory contact at the country level, coordinating translations, regulatory document review, and local SOP adherence to ensure timely study starts and compliant

Qualifications

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science.
• Minimum two years of experience in clinical research, preferably in site activation and/or regulatory-related function.
• Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations.
• Multilingualism preferred; fluent in local language; working knowledge of English.

Responsibilities

• Support end-to-end site start-up from site identification to activation and maintenance, serving as the primary site contact.
• Act as country-level regulatory and site activation lead for assigned studies.
• Customize country-specific patient information sheets, informed consent forms, labels and regulatory documents to comply with ICH GCP and local rules.
• Review country timelines for assigned studies and provide guidance as needed.

Skills

Regulatory coordination

Site activation management

Regulatory strategy advice

Multilingual communication

Project coordination

Education

Bachelor-level degree in life sciences

Tools

MS Office (Word/Excel/PowerPoint)

Job description

Who we are

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. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote 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. Join us!

Summary

Subject matter expert and local point of contact for activities supporting Regulatory submissions, site activation and maintenance for awarded projects. Responsible for planning, initiating and tracking documents required for regulatory submissions, essential documents collection, review and provision of country/site/EC requirements to support achievement of site activation goals and communicating status, risks and actions related to any start-up activities and maintenance when applicable.

Responsibilities

Tasks may include but are not limited to:

• Responsible for supporting end-to-end site start-up from site identification to site activation and maintenance serving as the primary point of contact for the site
• Act as internal primary point of contact at country level for regulatory and site activation activities in the assigned studies
• Responsible for customization of country specific patient information sheet, informed consent form, labels and local regulatory documents to comply with ICH GCP & country specific requirements
• Review and provide advice on country timelines for the assigned studies
• Effectively communicate to the Regulatory Affairs Manager (RAM) and relevant project team members the status and action plans concerning submissions
• Collect, receive, and perform first review of required study-specific site regulatory/essential documents in accordance with applicable SOPs, guidelines and relevant study specific plans
• Track study-specific regulatory documents by site and/or country and follows up with sites or internal team members as needed and reports to the RAM
• Proactively identify risks and generate mitigation strategies at country/site level
• Advise the RAM/project team about appropriate country regulatory strategies
• Maintain regular communication with sites to ensure timely completion of start-up and maintenance activities
• Provide timely and relevant updates of changing regulatory requirements, support on interpretation of new regulations, and maintain regulatory intelligence database for the assigned country
• Be familiar with and comply with SOPs, ICH GCP and applicable regulations
• Where required provide local QC of submission dossiers prior to dispatch
• May act as a contact point for translation review of submissions documents such as application, synopsis, ICF, labels etc.
• Perform other duties as assigned

The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Other skills and abilities

• 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
• Proactive by identifying potential issues in the process and anticipating solutions
• Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel
• Easily adjusts to a changing environment; ability to prioritize adapt between detailed and strategic activities while maintaining delivery timelines and quality
• 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

Requirements

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science
• Minimum two year of experience in clinical research, preferably in site activation and/or regulatory-related function
• Preferred minimum of one year of previous experience within the pharmaceutical/CRO industry
• Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations
• Multilingualism preferred; fluent in local language; working knowledge of English
• Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently

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.

This is who we are. We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.