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Job Title: Specialist, Regulatory & Site Activation
Job Location: Virtual India
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
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, e**ssential 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 siteAct as internal primary point of contact at country level for regulatory and site activation activities in the assigned studiesResponsible for customization of country specific patient information sheet, informed consent form, labels and local regulatory documents to comply with ICH GCP & country specific requirementsReview and provide advice on country timelines for the assigned studiesEffectively communicate to the Regulatory Affairs Manager (RAM) and relevant project team members the status and action plans concerning submissionsCollect, 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 RAMProactively identify risks and generate mitigation strategies at country/site levelAdvise the RAM/project team about appropriate country regulatory strategiesMaintain regular communication with sites to ensure timely completion of start-up and maintenance activitiesProvide timely and relevant updates of changing regulatory requirements, support on interpretation of new regulations, and maintain regulatory intelligence database for the assigned countryBe familiar with and comply with SOPs, ICH GCP and applicable regulationsWhere required provide local QC of submission dossiers prior to dispatchMay 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 skillsStrong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.Self-motivated learning about current regulatory processes and intelligenceExcellent written and verbal communication skills to clearly and concisely present informationProactive by identifying potential issues in the process and anticipating solutionsThorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnelEasily adjusts to a changing environment; ability to prioritize adapt between detailed and strategic activities while maintaining delivery timelines and qualityTeam-oriented work style; seeks and gives guidance to othersStrong interpersonal skills in a fast-paced, deadline oriented, and changing environmentExcellent ability to handle multiple tasks in a fast-paced and changing environmentProficiency in all MS-Office applications including Microsoft Word, Excel, and PowerPointAptitude 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 scienceMinimum two year of experience in clinical research, preferably in site activation and/or regulatory-related functionPreferred minimum of one year of previous experience within the pharmaceutical/CRO industryGood knowledge of ICH GCP, relevant clinical research conduct guidance and country regulationsMultilingualism preferred; fluent in local language; working knowledge of EnglishPromotion 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 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 .
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