Remote Regulatory Affairs Pharmacist Job Description

Shape the Future of Healthcare Compliance—From Anywhere

Are you passionate about ensuring pharmaceutical integrity in a fast-paced, digital-first world? As a Remote Regulatory Affairs Pharmacist, you will play a pivotal role in safeguarding drug quality, upholding regulatory standards, and streamlining product registration processes from the comfort of your remote workspace. This is your opportunity to merge your scientific expertise with strategic tech-driven operations, all while being a vital contributor to a mission-oriented team that thrives on innovation and precision.

With an annual salary of $121,078, this role offers more than compensation—it provides purpose, professional advancement, and a direct impact on global health outcomes.

About the Role

In this fully remote position, you will serve as a bridge between regulatory authorities and internal departments, driving compliance efforts, enhancing documentation systems, and preparing electronic submissions using cutting-edge regulatory software. Your insights will shape critical decisions and ensure alignment with global health regulations.

Key Responsibilities

1. Regulatory Documentation & Submission

• Draft, compile, and submit regulatory dossiers for new and existing products via electronic Common Technical Document (eCTD) platforms.
• Maintain up-to-date records within validated document management systems, such as Veeva Vault.
• Coordinate lifecycle management activities for marketed products, including variations and renewals.

2. Compliance Monitoring & Risk Management

• Monitor ongoing global regulatory changes across the FDA, EMA, Health Canada, and MHRA.
• Support internal audits and external inspections by preparing technical files and audit trails.
• Conduct gap analyses to identify potential non-compliance risks and develop proactive mitigation strategies.

3. Cross-Functional Collaboration

• Collaborate with quality assurance, clinical, medical writing, and supply chain teams.
• Provide strategic guidance during product development to ensure regulatory feasibility.
• Participate in virtual meetings with cross-regional stakeholders to align regulatory timelines.

4. Data-Driven Communication

• Generate performance reports using dashboards and data visualization tools.
• Present regulatory trends, status updates, and submission forecasts using tools like Tableau or Power BI.

Tools and Technology

This role leverages modern technologies to drive regulatory excellence:

• eCTD Software: GlobalSubmit, Lorenz docuBridge
• RIM Systems: Veeva Vault, Ennov
• Analytics: Power BI, Tableau, Excel with Power Query
• Document Tools: Adobe Acrobat Pro, MS Office Suite
• Communication Platforms: Microsoft Teams, Slack, Zoom

Tech fluency is central to your success here. Expect a high-tech environment that values digital optimization, streamlined workflows, and innovative documentation practices.

Work Environment

A Remote-First Approach

This role is part of a forward-thinking, cloud-native team. You'll work remotely with:

• Flexible hours tailored around productivity and autonomy
• Paperless processes through cloud-based documentation platforms
• Real-time collaboration via agile sprint boards and digital feedback tools

Culture of Continuous Innovation

You will be embedded in a performance-driven culture that embraces experimentation, iterative improvement, and shared learning.

• Monthly innovation retrospectives
• Regulatory tech hackathons and compliance sprint reviews
• Team workshops focused on new regulatory automation strategies

Qualifications and Competencies

Required Skills

• Current pharmacist license (U.S. or international equivalent)
• Minimum of 3 years in regulatory affairs within the pharmaceutical, biotechnology, or medical device sector
• Demonstrated experience with eCTD submissions and health authority communications
• Deep understanding of GxP regulations, ICH guidelines, and applicable ISO standards
• Strong communication skills—both written and verbal—with the ability to relay complex information concisely
• Experience working in a digital or remote setting

Preferred Skills

• Certification in Regulatory Affairs (RAC)
• Familiarity with structured content authoring tools (e.g., XML, SPL)
• Prior exposure to regulatory intelligence platforms like Cortellis or Elsevier PharmaPendium

Why You Should Apply

Here, your influence will be tangible. You'll support life-changing healthcare initiatives and ensure compliance at a global level—all while working from wherever you are most effective.

Perks of the Position

• Competitive salary: $121,078 annually
• Fully remote work with flexible scheduling
• Generous PTO and paid volunteer days
• Annual professional development budget for certifications or continuing education
• Access to compliance webinars, regulatory thought-leader panels, and virtual symposia
• Digital wellness stipends and ergonomics consultations

Career Growth and Learning

This role is designed for upward mobility. By joining a tech-empowered regulatory team, you will:

• Build expertise in international regulatory harmonization
• Contribute to the development of AI-assisted submission preparation tools
• Take part in mentorship programs led by industry leaders
• Co-author thought leadership articles and white papers on digital compliance trends

Make a Global Impact—Remotely

If you're ready to navigate the evolving regulatory landscape and bring transformative therapies to market, without stepping into an office, this role is your launchpad. Join a mission-driven team where technology and pharmacy intersect for real-world health impact.

Ready to Lead the Future of Remote Regulatory Excellence?

Take charge of your career with a role that places you at the forefront of tech-integrated healthcare compliance. Apply today to shape how safe, effective treatments reach the world—no commute required.