Regulatory Associate
Talent Groups ·www.talentgroups.com
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Hybrid Details: 3 days/week onsite
Duration: 5 months to start
Job Summary:
The Regulatory Associate is responsible for supporting regulatory submission management activities, pre-publishing, and the maintenance of regulatory documentation to ensure timely, accurate, and compliant Health Authority submissions. This role works cross-functionally with Regulatory Affairs and external publishing vendors to coordinate submission components, prepare dossiers for electronic submission and maintain regulatory records in accordance with internal procedures and global regulatory requirements.
Key Responsibilities
Submission Management Support
Qualifications
Education
Experience
Required Skills and Competencies
#LI-Hybrid
Duration: 5 months to start
Job Summary:
The Regulatory Associate is responsible for supporting regulatory submission management activities, pre-publishing, and the maintenance of regulatory documentation to ensure timely, accurate, and compliant Health Authority submissions. This role works cross-functionally with Regulatory Affairs and external publishing vendors to coordinate submission components, prepare dossiers for electronic submission and maintain regulatory records in accordance with internal procedures and global regulatory requirements.
Key Responsibilities
Submission Management Support
- 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 pre-publishing 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 work instructions, templates, and departmental tools related to submission management and publishing activities.
Qualifications
Education
- Bachelor’s degree in life sciences, Regulatory Affairs, or a related discipline required.
Experience
- 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.
Required Skills and Competencies
- 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.
#LI-Hybrid
Frequently asked questions
Who is hiring for the Regulatory Associate role?
Talent Groups is hiring for the Regulatory Associate position, a Shazamme client. Apply directly on the employer's career site.
Where is the Regulatory Associate job located?
The Regulatory Associate role with Talent Groups is based in Waltham, MA, US. The role is hybrid-friendly.
Is the Regulatory Associate role remote?
Yes — the Regulatory Associate position at Talent Groups is hybrid. Candidates based in US are preferred.
What does the Regulatory Associate role pay?
Talent Groups lists the Regulatory Associate role at USD 73–83 per hour.
Is the Regulatory Associate role full-time or contract?
This is a full time position at Talent Groups.
What experience level is the Regulatory Associate role?
The Regulatory Associate position is aimed at junior-level candidates.
How do I apply for the Regulatory Associate role at Talent Groups?
Apply directly on Talent Groups's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.