FDA Submission Documentation Specialist – Remote (USA)

Are you highly detail-oriented with a strong understanding of regulatory requirements in the medical, pharmaceutical, or biotech sectors? We are seeking an FDA Submission Documentation Specialist to join our remote team in the USA. In this pivotal role, you will be responsible for preparing, reviewing, and managing regulatory submissions to the U.S. Food and Drug Administration (FDA). If you have a passion for regulatory compliance and a deep knowledge of FDA documentation standards, this is a great opportunity to contribute to life-changing healthcare innovations from the comfort of your home.

Ensure Regulatory Excellence from Anywhere in the U.S.

A leading life sciences organization is hiring an FDA Submission Documentation Specialist to support its regulatory affairs operations remotely. The successful candidate will have a thorough understanding of FDA submission types (e.g., IND, NDA, ANDA, BLA, 510(k)), proficiency in eCTD format, and experience coordinating with cross-functional teams. If you are a self-motivated professional with a meticulous approach to regulatory documentation and a drive to support product approvals and market access, this remote position offers both flexibility and impact.

Key Responsibilities of the FDA Submission Documentation Specialist – Remote (USA)

Regulatory Documentation Management: Prepare, compile, and submit high-quality regulatory documents to the FDA, including INDs, NDAs, ANDAs, BLAs, 510(k)s, and amendments. Ensure all submissions meet current regulatory requirements, formatting standards, and timelines.

Cross-Functional Collaboration: Work closely with Regulatory Affairs, Clinical, Quality, and R&D teams to gather, organize, and validate data needed for submission. Ensure consistency and accuracy across all technical and scientific documents.

eCTD Publishing & Submission: Format and publish submission documents in electronic Common Technical Document (eCTD) format using appropriate software tools. Manage lifecycle submissions and track FDA communications and feedback.

Content Review & Quality Assurance: Conduct thorough reviews of submission documents for clarity, completeness, and compliance. Ensure that scientific, clinical, and manufacturing content is presented accurately and in a manner consistent with regulatory expectations.

Regulatory Intelligence & Compliance: Stay updated with evolving FDA guidelines, industry best practices, and regulatory changes. Integrate regulatory intelligence into documentation processes to enhance submission quality and approval timelines.

Timeline & Project Management: Manage multiple documentation projects simultaneously, ensuring timely submissions aligned with product development milestones. Maintain detailed records of submission histories, approvals, and agency correspondence.

SOP Adherence & Continuous Improvement: Follow internal standard operating procedures (SOPs) and contribute to the development and improvement of regulatory documentation practices. Support audits and inspections by maintaining audit-ready documentation files.

Communication & Reporting: Act as a liaison between internal teams and regulatory authorities, providing timely updates and clarifications when required. Document meeting minutes and formal communications with the FDA and other regulatory bodies.

What the Client is Looking for in You

As an FDA Submission Documentation Specialist, the client is seeking a highly detail-oriented and knowledgeable regulatory professional with a strong understanding of FDA submission requirements. You should be capable of managing complex documentation processes, collaborating across departments, and ensuring high-quality, compliant submissions. If you are organized, proactive, and have a passion for regulatory excellence, this role is an ideal fit.

Regulatory Expertise and Submission Experience

The client is looking for an experienced specialist with a strong background in preparing, formatting, and submitting regulatory documents to the FDA. You should have a working knowledge of key submission types such as IND, NDA, BLA, ANDA, and 510(k), as well as familiarity with eCTD standards and publishing tools. Prior experience in the pharmaceutical, biotechnology, or medical device industry is highly preferred.

Detail-Oriented and Process-Driven Professional

Accuracy and precision are critical in this role. The ideal candidate must demonstrate exceptional attention to detail, ensuring that all submission materials meet the highest standards of completeness, consistency, and regulatory compliance. A methodical approach to documentation and process adherence will be vital to your success.

Strong Communication and Team Collaboration

This role requires seamless coordination with cross-functional teams, including Clinical, Quality, Regulatory Affairs, and R&D. The client is looking for someone who can clearly communicate technical information, provide documentation guidance, and work effectively in a remote, collaborative environment.

Adaptability and Continuous Learning

The regulatory landscape is ever-evolving, and the client seeks a professional who stays informed of FDA updates, guidance documents, and industry trends. You should be proactive in applying new regulatory knowledge to submissions and open to improving existing processes to align with best practices.

Project Management and Time Efficiency

Managing multiple documentation projects with tight deadlines requires excellent time management and organizational skills. The ideal candidate will be capable of prioritizing tasks, tracking submission progress, and delivering high-quality documentation on schedule.

Commitment to Compliance and Ethical Standards

The client places high value on ethical conduct and regulatory compliance. You must demonstrate a strong understanding of regulatory standards, data integrity principles, and documentation best practices, ensuring that all submissions support transparent and compliant product approval pathways.

FAQs About the Role – FDA Submission Documentation Specialist – Remote (USA)

1. What are the key responsibilities of the FDA Submission Documentation Specialist?
As an FDA Submission Documentation Specialist, you will be responsible for preparing, reviewing, and submitting regulatory documentation to the FDA. This includes a wide range of submission types such as INDs, NDAs, BLAs, ANDAs, and 510(k)s. You will collaborate with cross-functional teams to gather required data, ensure compliance with eCTD formatting standards, and manage submission timelines. You will also support communication with the FDA and maintain detailed documentation records.

2. What qualifications and experience are required for this position?
The ideal candidate should have prior experience working in regulatory affairs within the pharmaceutical, biotech, or medical device industry. A strong understanding of FDA submission types and eCTD formatting is essential. Familiarity with regulatory documentation tools and the ability to interpret and apply FDA guidance documents is also required. A degree in life sciences, pharmacy, regulatory affairs, or a related field is preferred.

3. What technical skills are important for this role?
Proficiency in regulatory submission software, eCTD publishing tools, and document management systems is highly valued. Strong written communication skills, attention to detail, and the ability to manage multiple projects simultaneously are critical. Knowledge of Microsoft Office and electronic document management systems (EDMS) is also expected.

4. What challenges might I face in this role?
This role involves managing complex regulatory requirements and tight submission deadlines. You may encounter challenges related to evolving FDA guidelines, data accuracy, and coordinating across multiple departments. Ensuring consistent quality across all documentation and responding to regulatory feedback efficiently are also key aspects of the role.

5. Is this a fully remote position, and what is the work schedule like?
Yes, this is a fully remote position open to candidates based in the USA. You will work standard business hours in your time zone, with occasional adjustments to accommodate project deadlines or team meetings across time zones. The role offers flexibility, but a high level of accountability and independent work ethic is expected.

6. What is the company’s culture and team environment like?
The company promotes a collaborative, detail-focused, and quality-driven work environment. Even though the role is remote, the team stays closely connected through regular virtual meetings and strong cross-functional collaboration. The organization values precision, integrity, and continuous learning in regulatory practices.

What Remuneration Can You Expect from This Job?

As an FDA Submission Documentation Specialist working remotely in the USA, you can expect a competitive compensation package aligned with your experience, technical skillset, and the regulatory complexity of the role. The remuneration for this position typically includes:

1. Base Salary

The base salary for an FDA Submission Documentation Specialist generally ranges from $80,000 to $120,000 per year, depending on your background, years of experience, and the scope of regulatory documentation handled (e.g., IND, NDA, BLA, 510(k)). Specialists with advanced experience or those working on high-stakes or high-volume submissions may command higher base salaries.

2. Performance-Based Incentives

Many companies offer annual performance bonuses based on individual contribution, accuracy of submissions, compliance performance, and adherence to project timelines. These bonuses often range from 5% to 15% of the base salary.

3. Remote Work Flexibility

This is a fully remote position, allowing you to work from anywhere within the United States. In addition to offering flexibility, many companies also provide a remote work stipend or reimbursement for internet and home office setup.

4. Health and Wellness Benefits

You can expect a comprehensive benefits package that typically includes:

Medical, dental, and vision insurance
Health Savings Account (HSA) or Flexible Spending Account (FSA)
Mental health support programs
Paid time off (PTO) and paid holidays
Short-term and long-term disability coverage

5. Retirement and Financial Benefits

Most employers offer retirement savings plans such as a 401(k) with company match. Some also provide financial planning resources and equity-based benefits depending on company structure.

6. Professional Development Support

Given the evolving nature of FDA regulations, companies often support ongoing training and certifications, including:

Reimbursement for regulatory affairs certifications (e.g., RAC)
Access to webinars, workshops, and industry conferences
Subscription to regulatory intelligence tools or platforms

Total Compensation Potential

When combining base salary, bonuses, and benefits, the total compensation package for an FDA Submission Documentation Specialist typically ranges from $90,000 to $140,000 annually. Top-tier candidates with extensive experience and niche regulatory expertise may receive offers on the higher end of this scale.

How to Apply

Are you an experienced regulatory documentation professional with a deep understanding of FDA submissions? We invite you to apply for the FDA Submission Documentation Specialist – Remote (USA) role. This is a critical opportunity to contribute to the successful development and approval of life-changing healthcare products by ensuring timely, compliant, and high-quality regulatory submissions.

To apply, please submit your updated resume along with a cover letter that outlines your experience with FDA submission types (e.g., IND, NDA, BLA, ANDA, 510(k)), eCTD formatting, regulatory writing, and cross-functional collaboration. Be sure to highlight your attention to detail, ability to meet deadlines under pressure, and any experience with electronic document management systems or publishing tools.

This remote role offers a chance to work in a highly regulated and rewarding environment where your expertise directly supports product innovation and patient safety. If you are passionate about regulatory affairs and thrive in a fast-paced, compliance-driven role, we encourage you to apply today.

For more details or to explore similar regulatory opportunities, please visit our Regulatory Affairs Careers Page.

Job Category: Medical Device

Job Type: Full Time

Job Location: Remote (USA)

FDA Submission Documentation Specialist – Remote (USA)