15 Aug
|
Cencora
|
Regina
If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. 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 our 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.
Quality check and provide accurate feedback on all submission types. Save submissions to external media and arrange for parcel delivery (if required). 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. 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; 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. Lead and complete PRCI projects if assigned by their manager. This includes collaboration and coordination with team members,
answering questions, providing advice, creation of timelines, and tracking project status.
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 minimum Exceptional computer skills in advanced Microsoft Word, Adobe Acrobat, Excel and Power Point. Has a 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. Has a 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.
Is responsible for company supplied hardware and software; Ability to manage independently and obtain individual and department goals. Excellent project management skills – expected to see all projects through to completion. Expected to coordinate with RA and Regulatory Operations team members, and keep them apprised on submission status, in order to complete all projects on time.
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. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness.
This encompasses 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. To encourage your personal growth, we also offer a variety of training programs, career development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. Full time Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements.
Accessibility
Policy
When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment. 67,000 CAD - 102,960 CAD This posting is intended to fill an existing vacancy for our Senior Regulatory Operations Specialist role.
📌 Senior Regulatory Operations Specialist (Regina)
🏢 Cencora
📍 Regina