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Cmc Report Writer Jobs (NOW HIRING)

WorkLlama, Inc.

CMC Regulatory Scientist

Rahway, NJ · On-site

Responsibilities * Manage and prepare regulatory CMC dossiers, annual reports, renewals ... Strong interpersonal, oral, and written communication skills with professional English proficiency.

Legend Biotech US

Manager, Regulatory CMC

Somerset, NJ · On-site

Evaluate and interpret technical documentation, including development reports, validation protocols ... Excellent technical writing and document preparation skills with demonstrated experience authoring ...

Legend Biotech USA, Inc.

Evaluate and interpret technical documentation, including development reports, validation protocols ... Excellent technical writing and document preparation skills with demonstrated experience authoring ...

Kardigan

Senior Director, CMC Regulatory

Princeton, NJ · On-site

$241K - $300K/yr

Regulatory Affairs Reports To : Head of CMC Regulatory Location: Princeton, NJ (onsite 4 days per ... Strong interpersonal, communication (oral and written), and organizational skills * Ability to ...

Codera

Director, CMC - Formulations

San Diego, CA · Remote

$190K - $260K/yr

Provide scientific input for analytical protocols and study reports * Contribute to a fast-paced ... Experience writing and/or reviewing regulatory documents, including Investigational New Drug (IND ...

US Tech Solutions

CMC Manager

Morristown, NJ · On-site

... health authorities including writing of expert statements and scientific justifications ... Ability to understand technical reports (stability, validation, manufacturing) * Experience in ...

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How much do cmc report writer jobs pay per year?

As of Sep 14, 2026, the average yearly pay for cmc report writer in the United States is $76,608.00, according to ZipRecruiter salary data. Most workers in this role earn between $42,000.00 and $94,500.00 per year, depending on experience, location, and employer.

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Infographic showing various Cmc Report Writer job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 17% Part Time, 1% Temporary, 2% Contract, and 1% Nights. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $76,608 per year, or $36.8 per hour.

Associate Director / Director, Regulatory Affairs CMC

Bothell, WA • On-site

Immunome, Inc.
Biotechnology Research and Development • 11 - 50 employees
Learn more about Immunome, Inc.external

Full-time

Re-posted 11 days ago

Job description

Position Overview

Immunome is seeking an Associate Director / Director, Regulatory Affairs CMC, responsible for developing and executing global regulatory CMC strategies across multiple modalities. This individual will manage key deliverables and ensure adherence to accelerated regulatory submission schedules. Reporting into the Senior Director, Regulatory Affairs CMC, the role is responsible for communications and interactions with global regulatory authorities. This person will collaborate cross-functionally with teams including Technical Operations, Quality Assurance, Supply Chain Management, and Project Management to maintain alignment with regulatory CMC strategies and compliance requirements.  

Responsibilities

  • Develop and execute global regulatory CMC strategies across clinical and commercial stages. 
  • Serve as the regulatory CMC lead on cross-functional teams, providing strategic input to technical operations, supply chain, quality and project teams. 
  • Author, review and manage the preparation of high-quality CMC sections for regulatory submission (e.g. IND, CTAs, IMPD, annual reports, pediatric plans, amendments, and marketing applications). 
  • Lead interactions with global health authorities on CMC topics, including preparation of briefing packages, responses to information requests, and representation at meetings. 
  • Collaborate with internal and external stakeholders to ensure regulatory compliance and alignment with regulatory CMC strategies. 
  • Maintain current knowledge of regulations and guidelines (e.g., ICH, FDA, EMA) and keep abreast of changes in the global regulatory environment. 
  • Support regulatory inspections, as required. 

Qualifications 

  • Bachelor's degree in a relevant scientific discipline required; advanced degree a plus. 
  • A minimum of 7 years of relevant pharmaceutical/biotechnology industry experience, including 5+ years in regulatory CMC, or equivalent experience.  
  • Hands-on experience with CMC submission preparation for small molecules, biologics, and/or antibody-drug conjugates. 
  • Experience with regulatory CMC strategy development and health authority interactions. 

Knowledge and Skills 

  • Deep understanding of ICH, FDA and EMA guidelines. 
  • Outstanding communication, analytical, organizational and time management skills. 
  • Strong written and verbal communication abilities with attention to detail. 
  • Ability to effectively lead cross-functional teams. 
  • Flexible work style with a pragmatic approach to rapidly changing priorities. 
  • Proficiency in submission management software, such as Veeva RIM. 

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