Regulatory Writers

Alphanumeric Systems; Raleigh (NC); Remote; USD 55,000 - 62,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is urgently seeking a mid-level Regulatory Writer to provide support for NDA submissions. The ideal candidate should have substantial experience in preparing regulatory documents, with a deep understanding of compliance and ICH guidelines. This remote contract position is perfect for a detail-oriented writer ready to contribute to impactful projects swiftly.

Qualifications

• 3-5 years of regulatory writing experience in pharmaceutical, biotechnology, or medical device industries.
• Proven track record in authoring and managing regulatory documents.
• Expert level understanding of pharmaceutical clinical study protocols.

Responsibilities

• Prepare and author regulatory documents such as INDs, NDAs, and Briefing Documents.
• Collaborate with subject matter experts to gather and interpret scientific data.
• Participate in planning and content development meetings for document strategy.

Skills

Communication

Attention to Detail

Organizational Skills

Regulatory Understanding

Education

Bachelor's or advanced degree in Life Sciences

Tools

Microsoft Office

Document Management Systems

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

Regulatory Medical Writer - NDA Submission Support

Location: Remote | Contract (Immediate Need)

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 are seeking a skilled Regulatory Medical Writer with direct experience preparing submission-ready documents for NDA filings. This includes authoring and editing SOPs, study protocols, investigator brochures, regulatory response documents, and Module 2 summaries. Familiarity with FDA expectations and a strong understanding of ICH and GDPs guidelines is required. This role is ideal for experienced regulatory medical writers who can step in quickly and contribute to the development of SOPs, protocols, and regulatory documents. We are seeking a detail-oriented and experienced Regulatory Writer to join our Regulatory Affairs team. In this mid-level role, you will be responsible for preparing, reviewing, and editing high-quality regulatory documents that support the development and approval of pharmaceutical products.

Key Responsibilities

• Prepare and author regulatory documents such as Clinical Study Reports (CSRs), Investigator Brochures (IBs), Protocols, INDs, NDAs, MAAs, and Briefing Documents in accordance with ICH and regional regulatory requirements.
• Collaborate with subject matter experts to gather and interpret scientific data.
• Ensure consistency, clarity, and accuracy in content and language, while maintaining compliance with relevant regulations and guidelines
• Ensure all content meets regulatory and internal quality standards
• Participate in planning and content development meetings to define document strategy, timelines, and deliverables.
• Conduct peer reviews and QC checks of documents prepared by team members.
• Track document development processes, timelines, and version control using document management systems (e.g., Veeva, Documentum).
• Support responses to regulatory authority questions by preparing high-quality written materials.
• Collaborate closely with cross-functional teams including client's Clinical, Safety, CMC, and Regulatory Affairs to ensure the timely and compliant delivery of submission-ready documentation
• Understand the sense of urgency required working within the NDA submission guidelines and impact on downstream processes with delays in meeting deadlines
  
  

Job Requirements

Qualifications

Education & Experience:

• Bachelor's or advanced degree in a Life Sciences field or a related field
• 3-5 years of regulatory writing experience in the pharmaceutical, biotechnology, or medical device industry.
• Proven track record in authoring and managing regulatory documents across multiple phases of development.
• Medical Writing experience and expert level understanding of pharmaceutical clinical study protocols
  
  

Skills & Competencies

• In-depth understanding of US regulatory requirements and guidelines
• Global experience is a plus, but not required
• Excellent written and verbal communication skills.
• Strong organizational skills and attention to detail.
• Ability to interpret complex clinical and scientific data.
• Proficiency in Microsoft Office and document management systems.
• Ability to manage multiple projects and deadlines with minimal supervision.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Marketing, Public Relations, and Writing/Editing

• Industries

  Pharmaceutical Manufacturing

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