Regulatory Operations Contractor

Dennis Partners; United Kingdom; Remote; GBP 40,000 - 60,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Regulatory Affairs Operations Contractor (Senior Associate level) to manage electronic document submission processes. This fully remote role requires 3+ years of experience in Regulatory Operations and proficiency in eCTD systems, Microsoft Word, and Adobe Acrobat. Responsibilities include maintaining regulatory databases and supporting Medical Writing. Ideal candidates will have a BA/BS degree and strong document management skills.

Qualifications

• 3+ years in the pharmaceutical industry Regulatory Operations arena.
• Advanced user skills using Microsoft Word and Adobe Acrobat.
• Experience with eCTD Software System.

Responsibilities

• Maintain global regulatory information and documentation databases.
• Electronically publish regulatory submission documents.
• Execute business implementation of electronic document management systems.

Skills

eCTD Software System

Microsoft Word

Adobe Acrobat

Regulatory Operations

Document Management System

Education

BA/BS degree

Tools

Microsoft Excel

Microsoft Project

Job description

This commercial-stage biopharmaceutical company is focused on developing, manufacturing, and commercializing innovative therapies for diseases and conditions of the eye. They are seeking a Regulatory Affairs Operations Contractor (Senior Associate level) who can provide electronic document management coordination & services (templates, formatting, proof-reading, publishing, and archiving) for regulatory submission documents and the source documents that support them. You will execute the business implementation and life cycle management of electronic document management systems (EDMS) and associated business processes. This engagement is approximately 40 hours a week for six months, covering while someone is out on maternity leave. This is a fully remote position.

Responsibilities:

• Maintain and administer the global regulatory information and documentation databases.
• Electronically publish regulatory submission documents to industry and company defined standards (INDs, NDAs, CTA, MAA, eCTD, NeES, etc.)
• Electronically publish regulatory submissions using the eCTD software suite to industry and company defined standards.
• Maintain ClinTrials.gov
• Adhere to assigned timelines for global regulatory submissions.
• Support Medical Writing in the tracking, preparation, and finalization of Clinical Study Reports within the enterprise document management system, and liaison with Clinical Quality Assurance (CQA) to process the Clinical Study Reports through the CQA approval process.
• Serve as a primary user and business expert of the eCTD software suite.
• Provide business user support for the workflow of regulatory submission documents through the document management system.
• Execute assigned activities for eCTD life‑cycle document management within the document management system and the eCTD software suite.
• Support maintenance of Trial Master Files in electronic format.
• Execute, adhere to, and recommend improvements to Regulatory Operations work practices and guidelines.
• Execute Regulatory Operation’s quality assurance processes on electronic submission documents and the validation processes for eCTD submissions as directed.
• Execute and maintain processes for Regulatory Affair’s global submissions, correspondences, and commitments in accordance with Good Documentation Practices.
• Maintain the eCTD word processing templates and train users on their functionality.
• Maintain the eCTD viewing system docbase archives/regulatory submission archives.
• Execute computer system validation test scripts as directed.
• Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.

Qualifications:

• 3+ years in the pharmaceutical industry Regulatory Operations arena is required.
• 3+ years of hands‑on experience with an eCTD Software System is required.
• 3+ years of advanced user skills using Microsoft Word and Adobe Acrobat desktop publishing techniques for regulatory submission documents are required.
• 3+ year of user experience within an enterprise Document Management System is required.
• 3+ year user experience with industry leading RIMS and EDMS systems is required.
• Knowledge of the industry standards for desktop publishing regulatory submission documents, including Case Report Forms, to eCTD readiness is desired.
• Experience publishing Clinical Study Reports to ICH E3 standards for use in eCTDs is desired.
• Experience on a cross‑disciplinary Regulatory Submission Team from the Regulatory Operations services perspective is desired.
• Experience with Microsoft Excel and Microsoft Project is desired.
• General knowledge of Computer System Life Cycle Management techniques is desired.
• BA/BS degree is preferred

Our client prefers candidates on the East Coast. All candidates must be authorized to work in the US. Visa sponsorship or transfers are not available for contract positions.