Senior Regulatory Operations Specialist

Job not on LinkedIn

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Recruiting.com

WebsiteLinkedInAll Job Openings

11 - 50 employees

🎯 Recruiter

☁️ SaaS

🤝 B2B

💰 Private Equity Round on 2006-06

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.

📋 Description

• Build and maintain a positive and productive liaison with internal and external contacts • 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 within company systems as per company standard • Create and format e-compliant documents as per clients’ needs using Microsoft Word, Adobe Acrobat (and associated plug-ins), Excel, and Power Point • Create eCTD submissions using an eCTD submissions builder, validation software, and an electronic submissions viewer • Create NeeS submissions, as needed, and coordinate any necessary shipments • Quality check and provide accurate feedback on all submission types • Independently troubleshoot and fix issues on a document and submission level • Send eCTD submissions via the ESG NextGen Portal • Save submissions to external media and arrange for parcel delivery (if required) • Enter time into the company time recording system on a daily basis • Attend and contribute to weekly department meetings, helping bring innovative solutions to promote growth and new business • Assist in writing marketing materials, if required • Maintain professional regulatory and documentary knowledge to provide effective consulting advice • Coordinate work ensuring all submissions and communications are covered fully, accurately, and completely to department standards • Effectively manage and prioritize both billable and unbillable work • Effectively delegate work to ensure all submissions are available for external QC in a timely manner • Assist with the creation and review of process documentation/SOPs • Involved with training of other department members, as needed • Publish, validate, and submit XML Product Monographs and SPLs if assigned • Create ASCII datasets as needed if assigned • Troubleshoot and mitigate IT issues within the department and provide systems-related support if assigned • Lead and complete PRCI projects if assigned • Complete additional department services as required

🎯 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 with one another • Results oriented with proven time management, organization and prioritizing skills • Must have an acute ability for attention to detail • Ability to work well individually and as a team • Responsibility for company supplied hardware and software; contacting Innomar IT when needed for assistance • Ability to manage independently and obtain individual and department goals • Excellent project management skills – expected to see all projects through to completion

🏖️ Benefits

• Medical, dental, and vision care • Backup dependent care • Adoption assistance • Infertility coverage • Family building support • Behavioral health solutions • Paid parental leave • Paid caregiver leave • Professional development resources • Mentorship programs