Senior Regulatory Operations Specialist

This is a fully remote position, open to applicants in Canada.

📋 Description

• Develop and sustain a constructive and efficient relationship with both internal and external stakeholders.

• Utilize various internet document transfer platforms to download client files and upload documents prepared for client delivery.

• Manage and maintain submission files within the company systems according to established standards.

• Create and format e-compliant documents tailored to clients' specifications using Microsoft Word, Adobe Acrobat (and related plugins), Excel, and PowerPoint.

• Generate eCTD submissions utilizing an eCTD submission builder, validation software, and an electronic submissions viewer.

• Prepare NeeS submissions as necessary and coordinate any required shipments.

• Conduct quality checks and provide precise feedback on all types of submissions.

• Independently diagnose and resolve issues at both document and submission levels.

• Submit eCTD submissions via the ESG NextGen Portal.

• Archive submissions to external media and arrange for parcel delivery when required.

• Daily log time into the company’s time tracking system.

• Participate in and contribute to weekly departmental meetings, fostering innovative solutions to encourage growth and new business opportunities.

• Assist in the creation of marketing materials as needed.

• Maintain professional regulatory knowledge and documentation to offer effective consulting advice.

• Coordinate efforts to ensure all submissions and communications are comprehensive, accurate, and adhere to departmental standards.

• Efficiently manage and prioritize both billable and non-billable tasks.

• Delegate tasks effectively to ensure timely availability of all submissions for external quality control.

• Aid in the development and review of process documentation and standard operating procedures (SOPs).

• Participate in training other department members as needed.

• Publish, validate, and submit XML Product Monographs and SPLs as assigned.

• Create ASCII datasets as necessary when assigned.

• Troubleshoot and resolve IT issues within the department and provide systems-related support as assigned.

• Lead and complete PRCI projects when designated.

• Fulfill additional departmental services as required.

⛳️ Requirements

• Bachelor of Science in life sciences.

• Generally 5-7 years of practical experience in Regulatory Operations.

• A minimum of 5+ years of hands-on experience in Regulatory Operations.

• Exceptional knowledge of various submission types (Canadian and U.S.).

• Strong written and verbal communication skills.

• Advanced computer proficiency in Microsoft Word, Adobe Acrobat, Excel, and PowerPoint.

• Comprehensive knowledge and skills in IT.

• Strong understanding of Non-eCTD electronic submissions (NeeS).

• Complete familiarity with all eCTD software utilized at Innomar.

• Excellent understanding of industry guidelines in Regulatory Operations and a general awareness of Regulatory Affairs guidelines.

• Ability to manage multiple projects and ad-hoc requests simultaneously.

• Full comprehension of client confidentiality and the significance of not mixing project information.

• Results-driven with demonstrated time management, organizational, and prioritization skills.

• Must possess a keen attention to detail.

• Ability to collaborate effectively both independently and as part of a team.

• Responsibility for company-provided hardware and software; reaching out to Innomar IT for assistance when necessary.

• Capability to operate independently and achieve individual and departmental objectives.

• Strong project management skills, with an expectation to guide all projects 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.