Senior Specialist, Regulatory Operations

Jobgether; United States; Remote; USD 122,000 - 143,000; Full time

Benefits offered by this job

Bonus eligibility

Stock options

Job summary

Jobgether is seeking a Regulatory Operations professional to oversee the preparation and submission of regulatory documents. You will ensure technical accuracy and adherence to regional standards while coordinating with cross-functional teams to maintain readiness.

The role requires hands-on experience with eCTD publishing, RIM systems, and Word/Acrobat formatting. Remote work within the United States is available, with emphasis on timely, compliant deliverables.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Master’s degree in Regulatory Affairs is highly desirable.
• 4+ years of regulatory operations experience in pharma/biotech, with eCTD publishing and submission support.
• Working knowledge of eCTD lifecycle management and FDA/ICH standards.
• Strong MS Word and Adobe Acrobat skills, including formatting and bookmarking.
• Experience with a regulatory information management system (RIM).
• Attention to metadata, documentation, and regulatory records.

Responsibilities

• Oversee operational preparation and execution of regulatory submissions including INDs, CTAs, and health authority responses.
• Coordinate content handoffs, track actions, communicate delays, and escalate risks.
• Prepare submission-ready Word and PDF documents with quality checks.
• Publish and validate eCTD and non-eCTD packages using approved tools.
• Ensure submission delivery, monitor acknowledgments, and archive final records.
• Maintain regulatory information in Veeva RIM and support workflows.

Skills

Regulatory submissions

eCTD publishing

RIM familiarity

Cross-functional collaboration

Microsoft Word

Adobe Acrobat

Veeva RIM

Veeva PromoMats

Project coordination

Attention to detail

Education

Bachelor’s degree in life sciences

Master’s degree in Regulatory Affairs (desirable)

Tools

Veeva RIM

Adobe Acrobat

Microsoft Word

Job description

Accountabilities:

You will oversee the operational preparation and execution of assigned regulatory submissions, ensuring that documents and submission packages meet applicable technical standards and internal requirements. You will collaborate with cross-functional stakeholders to maintain submission readiness, resolve technical issues, and support continuous improvement across regulatory operations.

• - Manage routine regulatory submissions, including INDs, CTAs, application lifecycle submissions, meeting packages, and responses to health authority requests.
• - Support complex or high-priority filings under the guidance of the responsible Regulatory Operations Submission Manager.
• - Maintain submission plans, content trackers, milestones, delivery dates, and readiness status in collaboration with regulatory leads and project teams.
• - Coordinate with document owners to confirm content handoffs, track outstanding actions, communicate delays, and escalated risks promptly.
• - Prepare submission-ready Word and PDF documents, including formatting, conversion, bookmarking, hyperlinking, and technical quality checks.
• - Compile, publish, and validate eCTD and non-eCTD submission packages using approved tools and current regional specifications.
• - Perform document-level technical quality control, resolve publishing and validation issues, and conduct submission-level quality checks when qualified.
• - Coordinate authorized submission delivery, monitor transmission acknowledgments and delivery status, resolve technical rejections, and archive final records.
• - Create and maintain accurate regulatory information management records in Veeva RIM, including applications, submissions, documents, metadata, milestones, and health authority correspondence.
• - Support RIM workflows, data quality, user issue resolution, system changes, and collaboration with IT, Quality, and system business owners.
• - Provide technical support for promotional submissions, including FDA Form 2253, by coordinating approved content and required documentation.
• - Contribute to regulatory projects through action tracking, meeting follow-up, status reporting, system migrations, user acceptance testing, training, work instruction updates, and process improvements.

Requirements:

You will bring hands-on regulatory operations experience in the pharmaceutical or biotechnology industry, with a strong understanding of electronic submission preparation, publishing standards, and regulatory documentation. Success in this role requires technical precision, effective cross-functional communication, and the ability to manage multiple deliverables independently while maintaining high-quality records and meeting deadlines.

• - Bachelor’s degree in life sciences or a related discipline.
• - Master’s degree in Regulatory Affairs is highly desirable.
• - At least 4 years of regulatory operations experience in the pharmaceutical or biotechnology industry, including document preparation, eCTD publishing, and submission support.
• - Working knowledge of eCTD lifecycle management, applicable FDA and ICH technical standards, publishing validation, and document- and submission-level technical quality control.
• - Strong Microsoft Word and Adobe Acrobat skills, including document formatting, PDF preparation, bookmarking, hyperlinking, and troubleshooting.
• - Experience using a regulatory information management system (RIM) or a comparable validated document and submission management platform.
• - Strong attention to detail and a commitment to accurate metadata, documentation, and regulatory records.
• - Ability to organize concurrent deliverables, coordinate with multiple stakeholders, follow up on outstanding actions, and communicate risks promptly.
• - Ability to work independently within assigned responsibilities while collaborating effectively across regulatory and cross-functional teams.

Preferred qualifications:

• - Experience with Veeva RIM, Veeva PromoMats, or a comparable promotional content management workflow.
• - Experience supporting submissions to health authorities outside the United States.
• - Familiarity with FDA Form 2253 and post-approval submissions.
• - Experience supporting system migrations, user acceptance testing, work instruction development, or submission project tracking.

Benefits:

• - Annual salary range: $122,000–$143,000 USD.
• - Additional compensation: Total compensation may include a bonus, stock, benefits, and other applicable variable compensation.
• - Location-based compensation: Final compensation depends on experience, skills, certifications, work location, and other relevant factors.
• - Remote work: The position is listed as remote within the United States.