Regulatory Writers

Alphanumeric Systems; Raleigh (NC); Remote; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a skilled Regulatory Writer to support NDA submissions. This remote mid-level role demands expertise in regulatory writing, including authoring SOPs and clinical documents. You will collaborate with cross-functional teams to ensure compliance with FDA regulations while preparing high-quality submission-ready materials. If you have a keen eye for detail and a passion for the pharmaceutical industry, this opportunity offers a chance to make a significant impact in a fast-paced environment. Join us to contribute to the development of life-saving products and navigate the complexities of regulatory requirements.

Qualifications

• 3-5 years of regulatory writing experience in the pharmaceutical industry.
• Proven track record in authoring regulatory documents.

Responsibilities

• Prepare and author regulatory documents for NDA submissions.
• Collaborate with subject matter experts to gather scientific data.

Skills

Regulatory Writing

Clinical Study Reports (CSRs)

Investigator Brochures (IBs)

Protocols

INDs

NDAs

Attention to Detail

Communication Skills

Document Management Systems

Education

Bachelor's or advanced degree in Life Sciences

Tools

Microsoft Office

Veeva

Documentum

Job description

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.