Regulatory Submission Publishing Specialist

Position Title: Regulatory Submission Publishing Specialist

Location: United States

Working Model: Remote or Hybrid

Reports to: U.S. Regulatory Affairs Team

About Devatis, Inc.:

Devatis, Inc. is a dynamic and fast-growing pharmaceutical company specializing in the development, registration, and supply of high-quality generic medications. As part of our global network, we are committed to delivering affordable healthcare solutions with a focus on quality, compliance, and innovation. Our U.S. operations are expanding, and we are seeking talented professionals to help drive our success.

Position Summary:

The role is responsible for transforming regulatory documentation into technically compliant, submission-ready eCTD sequences and ensuring their accurate validation and transmission. Working closely with Regulatory Affairs, CMC, Quality, Medical Writing, and external service providers, the specialist will help deliver high-quality submissions in line with regulatory requirements and established timelines.

Key Responsibilities:

• Manage the end-to-end preparation, publishing, validation, and transmission of FDA submissions in eCTD format, including ANDAs, DMFs, amendments, supplements, annual reports, labeling submissions, information request responses, and controlled correspondence.
• Build and maintain technically accurate eCTD sequences, including XML backbones, lifecycle operators, metadata, hyperlinks, bookmarks, navigation elements, and submission-ready PDF documents.
• Conduct comprehensive technical quality checks, resolve publishing and validation errors, and ensure submissions comply with current FDA specifications and Electronic Submissions Gateway requirements.
• Coordinate publishing schedules and deliverables across Regulatory Affairs, CMC, Quality, Medical Writing, external vendors, and other stakeholders to support multiple products and meet concurrent regulatory deadlines.
• Maintain complete submission records and archives while contributing to publishing standards, templates, SOPs, process improvements, and the ongoing adoption of regulatory publishing best practices.

Qualifications:

Education & Experience

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Information Management, or a related discipline is preferred.
• At least 3 years of hands-on experience in eCTD publishing for FDA submissions.
• Demonstrated experience supporting ANDA, NDA, BLA, or DMF submissions and their associated lifecycle activities.
• Strong understanding of FDA eCTD requirements, electronic submission validation criteria, lifecycle management, and Electronic Submissions Gateway processes.
• Experience managing several submission activities simultaneously under time-sensitive deadlines.
• Practical experience with an established publishing platform such as Lorenz docuBridge, EXTEDO eCTDmanager, GlobalSubmit, Veeva Vault RIM/Submissions, or an equivalent system.
• Proficiency in PDF preparation and optimization, document formatting, hyperlinking, bookmarking, metadata management, and technical submission troubleshooting.

Preferred Qualifications

• Experience supporting U.S. generic pharmaceutical products and ANDA lifecycle activities.
• Familiarity with Regulatory Information Management and electronic document management systems.
• Experience supporting global regulatory submissions to the EMA, MHRA, Health Canada, or other international health authorities.
• Experience working with cross-functional and geographically distributed regulatory teams.
• Familiarity with collaboration platforms such as Microsoft SharePoint and Teams.

Key Competencies

• High level of accuracy and attention to detail.
• Strong planning, organization, and prioritization skills.
• Ability to work independently and manage competing deadlines.
• Effective technical problem-solving and troubleshooting capabilities.
• Clear written and verbal communication skills.
• Collaborative approach to working with internal teams and external partners.
• Commitment to quality, compliance, and continuous improvement.

What We Offer:

We offer a comprehensive benefits package designed to support your health, financial well-being, and work–life balance, including:

• Fully remote position within the United States
• Medical, dental, and vision insurance
• 401(k) retirement plan with Company matching
• Generous paid time off (PTO)
• 11 paid holidays

How to Apply

Interested candidates are invited to submit their resume and a cover letter outlining their experience in regulatory affairs within the pharmaceutical industry, including U.S. FDA submissions and related regulatory activities.

Applications may be submitted to [email protected], and we also welcome direct applications via Indeed.

Applicant Privacy Notice:
Devatis, Inc. collects and processes personal information you submit during the application process (e.g., name, contact details, resume, cover letter, salary expectations) for recruitment and hiring purposes only. We may share this information with service providers who assist us with recruitment under confidentiality obligations. We do not sell your personal information.
For details about how we handle your data and your rights under applicable U.S. state laws (e.g., California, Colorado, Virginia), please refer to our Devatis Applicant Privacy Policy* or contact us at [email protected].

This is a remote position; Devatis, Inc. provides reasonable accommodations to qualified individuals with disabilities during the recruitment process.

Devatis, Inc. is proud to be an Equal Opportunity Employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees.

*Devatis Applicant Privacy Policy

Devatis, Inc. ("Devatis," "we," "us," or "our") is committed to protecting your privacy during the job application process. This notice explains how we collect, use, and protect your personal information in connection with your application for a position with us. By submitting your application, you acknowledge that you have read and understand this notice.

1. Information We Collect We may collect the following personal information from you:

-Contact details (e.g., name, email, phone number, address).

-Professional information (e.g., resume, cover letter, work history, education, salary expectations).

-Other details you voluntarily provide (e.g., references, certifications).

We do not collect sensitive personal information (e.g., race, health data, or biometrics) unless required by law or with your explicit consent.

2. How We Use Your Information

Your information is used to:

-Evaluate your qualifications and suitability for the role.

-Communicate with you about the application process (e.g., interviews, status updates).

-Comply with legal obligations (e.g., equal employment reporting).

-Improve our recruitment processes (e.g., analytics, in aggregated form).

3. How We Share Your Information We may share your information with:

-Affiliates or service providers (e.g., background check vendors, HR software) under confidentiality agreements.

-Regulatory authorities if required by law. We do not sell your personal information.

4. Data Retention and Your Rights We retain your information for up to 2 years after the application process ends (or longer if legally required). Depending on your state of residence, you may have rights to access, correct, delete, or opt out of certain uses of your data (e.g., under CCPA in California). To exercise these rights, contact us at [insert privacy contact email].

For more details, see our full Privacy Policy at devatis.us/legal/privacy-policy. If you have questions, email [email protected] .

Job Type: Full-time

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: Remote