What are the responsibilities and job description for the Regulatory Submission Specialist position at GForce Life Sciences?
Regulatory Associate (CMC) Submission Management and Publishing Support
6 month contract
Must be able to work on a W2
Hybrid 3x per week in Waltham, MA
Requirements
- Support the planning, coordination, and execution of regulatory submissions, including INDs, IMPDs, amendments, and annual reports, as applicable.
- Assist with the compilation of submission content and ensure deliverables are received from functional contributors according to established timelines.
- Track submission milestones, deliverables, and dependencies to support on-time execution.
- Assist in preparing submission-related trackers, timelines, and status updates for internal stakeholders.
- Prepare regulatory documents for publishing by ensuring they meet technical and formatting requirements for electronic submission.
- Perform prepublishing quality checks, including verification of bookmarks, hyperlinks, document properties, table of contents, and file naming conventions.
- Support assembly of eCTD submission components in collaboration with internal teams and/or external publishing vendors.
- Conduct quality control reviews of published submission output to ensure completeness, accuracy, and compliance.
- Maintain regulatory documentation in document management systems, regulatory information management systems, and shared repositories, as applicable.
- Support maintenance of submission archives, correspondence logs, health authority communication records, and regulatory trackers.
- Support the maintenance of work instructions, templates, and departmental tools related to submission management and publishing activities.
Qualifications
- Bachelor’s degree in Life Sciences, Regulatory Affairs, or a related discipline required.
- 2–5 years of experience in Regulatory Affairs.
- Experience supporting electronic regulatory submissions and document preparation in a regulated environment preferred.
- Familiarity with eCTD structure, publishing processes, and submission-ready document requirements preferred.
- Strong organizational skills and the ability to manage multiple tasks and deadlines simultaneously.
- Excellent attention to detail and commitment to document quality and accuracy.
- Understanding of regulatory submission processes and document lifecycle management.
- Ability to work effectively in a cross-functional, fast-paced environment.
- Strong written and verbal communication skills.
- Proficiency in Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint; proficiency in Veeva RIM preferred.
- Ability to identify issues proactively and support timely resolution.
- Demonstrated ability to maintain confidentiality and handle sensitive documentation appropriately.