Regulatory Submission Publishing Specialist

Russell Tobin; United States; Remote; USD 48,000 - 51,000; Full time

Benefits offered by this job

Healthcare coverage

Dental & vision

401(k) retirement savings

Life & disability insurance

Employee assistance program

Legal support

Pet insurance

Employee discounts

Job summary

Russell Tobin seeks a Regulatory Submission Publishing Specialist to support end-to-end publishing of regulatory documents for global diagnostic products.

The role focuses on regulatory compliance, submission quality, and publishing systems across US, EU, and other markets, leveraging AI/RPA and automation to streamline processes.

Qualifications

• Minimum 5 years of experience in regulatory submission publishing.
• Strong knowledge of FDA, EMA, and ICH regulatory requirements.
• Experience with eCTD publishing tools and electronic submission gateways.
• Experience with AI, RPA, or publishing automation tools preferred.
• Strong organizational, communication, and problem-solving skills; ability to manage multiple deadlines.
• Experience with continuous improvement and process automation; leadership or mentoring is a plus.

Responsibilities

• Lead preparation, publishing, and electronic submission of regulatory dossiers (510(k), PMA, BLA, IND/IDE, IVDR).
• Use publishing platforms (Veeva Vault, LORENZ docuBridge FIVE, eCTD Xpress) to compile, validate, publish.
• Manage electronic submissions through FDA CCP/ESG, Notified Body portals, and EMA Gateway; resolve issues.
• Perform quality control checks and review validation reports for accuracy and compliance.
• Manage submission timelines, sequence planning, document traceability, and archiving.
• Collaborate with Regulatory Affairs, commercial teams, vendors, and IT to resolve publishing challenges.
• Maintain regulatory document repositories using Veeva Vault/RIM, DMS, CMS.
• Apply FDA/EMA/ICH guidelines; support process improvements and automation.
• Promote submission-ready standards and leverage AI/RPA to improve efficiency.

Skills

Regulatory knowledge

Attention to detail

Communication

Problem solving

Leadership (nice to have)

Education

Bachelor's degree in Life Sciences or related field

Advanced degree preferred

Tools

Veeva Vault

LORENZ docuBridge FIVE

eCTD Xpress

AI/RPA tools

FDA/EMA/ICH guidelines knowledge

Job description

Regulatory Submission Publishing Specialist | Regulatory Affairs | eCTD Publishing

Russell Tobin is seeking a Regulatory Submission Publishing Specialist to support the end-to-end preparation, publishing, and electronic submission of regulatory documents for global diagnostic products. This role focuses on regulatory compliance, submission quality, publishing systems, and process optimization across US, EU, and other global markets.

Responsibilities

• Lead the preparation, publishing, and electronic submission of regulatory dossiers for diagnostic products, including 510(k), PMA, BLA, IND, IDE, and IVDR submissions.
• Use publishing platforms such as Veeva Vault, LORENZ docuBridge FIVE, and eCTD Xpress to compile, validate, and publish submission packages.
• Manage electronic submissions through FDA CCP/ESG, Notified Body portals, and the EMA Common Gateway, resolving validation and upload issues.
• Perform quality control checks and review validation reports to ensure submission accuracy and regulatory compliance.
• Manage submission timelines, sequence planning, document traceability, and archiving requirements.
• Collaborate with Regulatory Affairs, commercial teams, vendors, and IT stakeholders to resolve publishing challenges.
• Maintain regulatory document repositories and publishing databases using systems such as Veeva Vault, Veeva RIM, DMS, and CMS.
• Apply FDA, EMA, and ICH guidelines while supporting process improvements, automation, and emerging regulatory requirements.
• Promote submission-ready documentation standards and leverage AI and robotic process automation (RPA) to improve publishing efficiency.

Requirements

• Bachelor's degree in Life Sciences, Regulatory Science, Quality Assurance, or a related field; advanced degree preferred.
• Minimum 5 years of experience in regulatory submission publishing within diagnostics or related life sciences industries.
• Strong knowledge of FDA, EMA, and ICH regulatory requirements, with familiarity with global regulatory pathways.
• Experience with eCTD publishing tools, electronic submission gateways, and regulatory document management systems.
• Experience with AI, RPA, or publishing automation tools is highly preferred.
• Strong organizational, communication, and problem-solving skills with the ability to manage multiple deadlines independently.
• Experience in continuous improvement and process automation; leadership or mentoring experience is a plus.

• Location model: 100% Remote
• Schedule: 1st Shift, standard business hours
• Position Type: 1 year contract with possibilities of extension
• Pay range: $35/hr - $37/hr

• comprehensive healthcare coverage (medical, dental, and vision plans)
• supplemental coverage (accident insurance, critical illness insurance and hospital indemnity)
• 401(k)-retirement savings
• life & disability insurance
• an employee assistance program
• legal support
• pet insurance
• employee discounts with preferred vendors

PrideGlobal and it's affiliates are an equal opportunity employer. We do not discriminate on the basis of the race, religious creed, color, national origin, ancestry, physical disability, mental disability, reproductive health decision making, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, veteran or military status, or any other characteristic protected by applicable federal, state, or local law.

PrideGlobal and it's affiliates are a Fair Chance employer. We consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local Fair Chance laws and ordinances, including, the California Fair Chance Act and all applicable local Fair Chance ordinances.

Accommodations

We are committed to providing reasonable accommodations to applicants and employees with disabilities. If you require a reasonable accommodation to participate in the application or interview process, or to perform the essential functions of this role, please contact us.

Only applicable for San Francisco Candidates: Under the San Francisco Lactation in the Workplace Ordinance, we will provide written notice of lactation accommodation rights, and this notice will automatically be given upon hiring, any inquiry of parental leave or lactation accommodation.

Only applicable for Kentucky positions: For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.