Job Description

Job Title: Site Readiness and Reg Specialist IIJob Location: Mumbai, Maharashtra, IndiaJob Location Type: On-siteJob Contract Type: Full-timeJob Seniority Level: Entry levelAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development and technology solutions across more than 20 therapeutic areas. With over 18,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.Develops awareness of regulatory legislation, guidance, and practice in the assigned regions/countries with the support from senior staff Completes the following activities for clinical trial applications performed according to European Clinical Trials Regulation No 536/2014 in the Clinical Trials Information System (CTIS) under supervision and in close collaboration with the Global Regulatory Submissions Lead (GRSL) colleagues: Completes Part I application information in Clinical Trial Information System (CTIS) Accurately uploads all Part I and Part II documents to CTIS Initiates the payment process for Part I and/or Part II submission fees and seeks approval from GRSL Monitors CTIS and promptly informs the GRSL of all received alerts in CTIS Ensures timely tracking of all submissions and approvals (decisions) in applicable tracking tools Uploads the final submitted package to the Trial Master File and performs functional reviews as applicable Performs a review of final submission documents as applicable and specifically performs QC of Part II applications (as delegated) Submits application/notifications in CTIS upon permission of GRSL Ensures high quality documents are uploaded and filed and systems are updated on an ongoing and timely basis making Fortrea ready for an audit at any time Escalates study issues appropriately and in a timely fashion Attends team and company meetings as applicable Performs other duties as assigned by management depending upon country and situational requirements with proper supervision (if applicable)Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.Fortrea Is Proud To Be An Equal Opportunity EmployerAs an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement.If you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: . Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.

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