Regulatory Writers

Alphanumeric Systems; Raleigh (NC); Remote; USD 70,000 - 100,000; Full time

Job summary

An established industry player is seeking a skilled Regulatory Writer to support urgent NDA submissions. This remote mid-level role involves preparing high-quality regulatory documents, collaborating with cross-functional teams, and ensuring compliance with US regulatory guidelines. Ideal candidates will have a strong background in regulatory writing within the pharmaceutical or biotech sectors, showcasing their ability to manage multiple projects and deadlines effectively. Join a dedicated team that values detail-oriented professionals ready to make a significant impact in the regulatory affairs landscape.

Qualifications

• 3-5 years of regulatory writing experience in pharma or biotech.
• Proven experience in authoring and managing regulatory documents.

Responsibilities

• Prepare and author regulatory documents for NDA submissions.
• Collaborate with experts to ensure compliance with regulations.

Skills

Regulatory Writing

Clinical Study Protocols

Excellent Communication Skills

Attention to Detail

Ability to Interpret Scientific Data

Education

Bachelor's or higher degree in Life Sciences

Tools

Microsoft Office

Document Management Systems (e.g., Veeva, Documentum)

Job description

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Job Title:

Regulatory Writer (Mid-Level)

Location:

Remote

Department:

Regulatory Affairs / Medical Writing

Job Type:

C2C / 1099

Reports to:

Scientific Director

Position Overview

We are supporting a potential new client with an urgent need for regulatory writing support in preparation for an NDA submission to the FDA.

We seek a skilled Regulatory Medical Writer with experience preparing submission-ready documents for NDA filings, including SOPs, study protocols, investigator brochures, regulatory response documents, and Module 2 summaries. Familiarity with FDA expectations, ICH, and GDPs guidelines is required. This role is ideal for experienced regulatory medical writers who can contribute quickly to SOPs, protocols, and regulatory documents. We are looking for a detail-oriented Regulatory Writer to join our Regulatory Affairs team. In this mid-level role, you will prepare, review, and edit high-quality regulatory documents supporting pharmaceutical development and approval.

Key Responsibilities

1. Prepare and author regulatory documents such as CSRs, IBs, Protocols, INDs, NDAs, MAAs, and Briefing Documents in accordance with ICH and regional requirements.
2. Collaborate with subject matter experts to interpret scientific data.
3. Ensure clarity, accuracy, and compliance with regulations and guidelines.
4. Maintain content quality standards.
5. Participate in planning meetings for document strategy and timelines.
6. Conduct peer reviews and QC checks of team documents.
7. Track document development using management systems like Veeva or Documentum.
8. Support responses to regulatory authority questions with high-quality written materials.
9. Work closely with cross-functional teams to ensure timely submission of documents.
10. Understand the urgency associated with NDA submissions and meet deadlines.

Job Requirements

Qualifications

• Bachelor's or higher degree in Life Sciences or related field.
• 3-5 years of regulatory writing experience in pharma, biotech, or medical devices.
• Proven experience in authoring and managing regulatory documents across development phases.
• Expertise in clinical study protocols and medical writing.

Skills & Competencies

• Deep understanding of US regulatory requirements and guidelines.
• Global experience is a plus.
• Excellent communication skills.
• Strong organizational skills and attention to detail.
• Ability to interpret complex scientific data.
• Proficiency in Microsoft Office and document management tools.
• Ability to manage multiple projects and deadlines independently.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Medical Writing / Regulatory Affairs