Senior Regulatory Operations Specialist

Responsibilities

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 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 the team to promote growth and new business; Assist in writing marketing materials, if required; Maintain professional regulatory and documentary knowledge in order to provide effective consulting advice; The Associate is the periodic back-up responsible for coordinating work, ensuring all submissions and communications are covered fully, accurately, and completely to the department standards; Effectively manage and prioritize both billable and unbillable work; As needed, effectively delegate work to ensure all submissions are available for external QC in a timely manner, meeting assigned deadlines; Assist with the creation and review of process documentation/SOPs; The Associate will be involved with training of other department members as needed, on a software, document, and submission level; Publish, validate, and submit XML Product Monographs and SPLs if assigned by their manager, including independently troubleshooting and fixing any issues; Create ASCII datasets as needed if assigned by their manager; Troubleshoot and mitigate IT issues within the department and provide systems-related support if assigned by their manager; Lead and complete PRCI projects if assigned by their manager, including collaboration and coordination with team members, answering questions, providing advice, creation of timelines, and tracking project status; The Associate may be asked to complete additional and other department services as required

Requirements

B.Sc in life sciences and/or typically 5-7 years of daily working experience in Regulatory Operations; At least 5+ years of daily hands-on Regulatory Operations experience; 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 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; 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, the team and the company; Responsibility for company supplied hardware and software and 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; 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 focusing on physical, emotional, financial, and social wellness; Backup dependent care; Adoption assistance; Infertility coverage; Family building support; Behavioral health solutions; Paid parental leave; Paid caregiver leave; Training programs; Professional development resources; Mentorship programs; Employee resource groups; Volunteer activities