Coordinator, Regulatory Submissions

2 months ago

Mumbai Maharashtra, India Fortrea Full time

As 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, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Under the direction of senior staff, assist with the formatting and compilation of regulatory submissions through such tasks as entering information into Tables of Contents and creating tabs and submission labels.

Provide support assistance to senior staff in the upkeep of regulatory authority submission and correspondence logs (add entries to Tables of Contents, file submission letters and other correspondence).

Generate routine submission cover letters to regulatory authorities and clients.

Track, inventory and organize individual components of regulatory submissions.

Perform document acceptability checks of submission components.

Liaise with the Publishing group in the generation of submissions.

Provide support assistance to senior staff in the oversight, final preparation and generation of submission documents.

Perform a quality check of final submission documents.

Update status reports and tracking sheets of ongoing and pending regulatory projects with input provided by senior staff.

Organise shipping of documentation to clients, regulatory authorities and within Fortrea.

Perform other job functions, such as word processing, as needed to accomplish the above listed duties

Perform other activities as required by management.

Training management (Curricula maintenance and updating, daily follow-up for trainings, Instructor Lead Course (ILC) creation, new users/existing users training management in Compliance wire (CW), etc.

Electronic Lab Notebook (ELN) support activities (spreadsheet validation, periodic review of users, user groups, templates etc.

Tru‐ vault Docs handling (controlled prints, uploading & routing of documents for review/approvals, Projects, SOPs, work instructions (WI), forms etc.

Activities related to upgradation of existing systems/software (e.g. Windows 10 migration, Project Olympus, RIMS 5 etc.)

Responsible for computerized System Validation

Scientific support systems like Deskman, FR5, Open lab, Empower as well as compliance and few DI aspects etc.

Fortrea is proud to be an Equal Opportunity Employer:
As 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.

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