Regulatory Operations Associate

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October 23

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Recruiting.com

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Recruitment • SaaS • B2B

Recruiting. com is a recruitment platform that collects personal and non-personal information from job seekers to be used by recruiters and hiring managers. Users can submit their resumes or fill out a short form to be considered for current and future job opportunities. The site emphasizes user privacy and allows users to manage their personal data, including modifying, changing, and deleting their information. Recruiting. com securely stores user data until they request deletion, providing a comprehensive recruitment solution for both job seekers and employers.

11 - 50 employees

🎯 Recruiter

☁️ SaaS

🤝 B2B

💰 Private Equity Round on 2006-06

📋 Description

• build and maintain a positive and productive liaison with internal and external contacts, including interfacing with potential clients • use various internet document transfer sites to download client files and upload files ready to be sent back to clients • use, manage and maintain submission files on the company shared drive and submissions drive as per company standard • create and format e-compliant documents as per clients’ needs using Microsoft Word, Adobe Acrobat (and associated plug-ins), Excel, Power Point • create eCTD submissions using the eCTD submissions builder, validation software and electronic submissions viewer • create NeeS submissions, as needed, and coordinate any necessary shipments • quality checking all submission types • trouble shoot and fix issues, on a document and submission level • send eCTD submissions via the ESG and CESG gateway • burn CDs/DVD’s, create appropriate labelling if required • create courier waybills, pack and ship submission materials if required • enter time into Paymo, or company chosen database, on a daily basis • attend and contribute to weekly department meetings • maintain professional regulatory and documentary knowledge to provide effective consulting advice • assist with the creation and review of process documentation / SOP’s • responsible for in depth training of other department members, as needed

🎯 Requirements

• B.Sc in life sciences • typically 5-7 years of daily working experience in Regulatory Operations • at least 5+ years of daily hands-on Regulatory Operations experience minimum • exceptional understanding of a wide variety of submission types (Cdn and U.S.) • excellent written and verbal communication skills • exceptional computer skills in advanced Microsoft Word, Adobe Acrobat, Excel and Power Point • advanced knowledge and skills in IT • high knowledge of Non-eCTD electronic Submissions (NeeS) • complete and thorough knowledge of all eCTD software used at Innomar • excellent understanding of Regulatory Operations industry guidances and a general understanding of Regulatory Affairs industry guidances • ability to multitask and balance several projects and ad-hoc requests at once • complete understanding of client confidentiality and the importance not to cross project information • results oriented with proven time management, organization and prioritizing skills • acute ability for attention to detail • ability to work well individually and as a team • positive attitude and works for the greater good of clients, team and company • responsible for company supplied hardware and software; contacting Innomar IT when needed for assistance • excellent project management skills – expected to see all projects through to completion • expected to take on, as assigned, with little to no assistance from Director of department • expected to coordinate with RA and Regulatory Operations team members, and keep them apprised on submission status • able to identify, trouble shoot and fix any issues which arise • correct document placement within the eCTD structure is understood • submissions should have virtually no errors upon first validation • able to identify, at all times during project, any progress on any specific task • coordinates, on their own, any project management meetings needed and reports back to Director any needed information • expected to keep accurate, up-to-date records as per company/department guidelines • ability to consistently meet extremely tight deadlines • excellent conflict resolution capabilities and ability to spearhead issues (professionally) and successfully solve as they arise

🏖️ Benefits

• medical, dental, and vision care • comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness • support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave • training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities