Senior CMC Regulatory Technical Writer

Role Summary

The CMC Regulatory Department is seeking a highly experienced and detail-oriented Senior CMC Regulatory Technical Writer to join our team. The ideal candidate will play a crucial role in the preparation and submission of high-quality CMC regulatory documents including Module 2 and Module 3 that support our registration activities for small molecule and biopharmaceutical therapeutic assets.

This position requires strong writing skills to clearly, concisely, and accurately position the drug development activities and science underpinning the quality of our medicines in CMC regulatory dossiers in alignment with global health authority requirements and expectations.

The ability to work collaboratively with cross-functional teams including CMC regulatory strategists, drug substance and drug product technical development and commercial manufacturing teams, and quality assurance is also required.

The selected candidate will be responsible for developing and maintaining a suite of CMC regulatory dossier templates.

This role is a technical writing position, and the successful candidate will work closely with the CMC regulatory strategist in fulfilling their responsibilities of the role, but will not be individually responsible for developing regulatory strategy for the assigned project.

Primary Responsibilities

• Prepare, review, and finalize high-quality regulatory submission documents for late-stage clinical phase applications (Phase 3) and marketing applications for small molecule and biopharmaceutical therapeutic assets.
• Write drug substance and drug product CMC sections of regulatory submissions including Module 2.3 and Module 3 of the CTD, which may include briefing documents for Health Authority consultations, as applicable.
• Work closely with CMC teams, including formulation, process development, analytical, and manufacturing groups to gather and compile necessary information for regulatory submissions.
• Author and maintain CMC regulatory dossier templates. Templates to be updated based on evolving guidelines relevant to CMC and ensure compliance in all submissions working closely with CMC regulatory policy and intelligence.
• Work closely with regulatory submission managers.
• Manage CMC regulatory submission workflows within the document management system within the company.
• Ensure accuracy, consistency, and completeness of data and narratives within regulatory documents.
• Manage timelines and deliverables for multiple projects, ensuring that all deadlines are met and potential delays are communicated in a timely manner.
• Provide guidance and training to other team members as needed.

Education and Required Skills

• Degree in Pharmacy or a relevant science/technical subject such as chemistry, biology, or related field.
• Minimum of 10 years within a CMC role in the pharmaceutical industry, with at least 5 years being directly involved with a CMC regulatory submission technical writing role.
• Significant knowledge of CMC-related regulatory requirements and guidelines (e.g., ICH, FDA, EMA) and experience with eCTD submissions.
• Exceptional technical writing skills with the ability to communicate complex scientific information clearly and concisely.
• Meticulous attention to detail and accuracy in all aspects of work.
• Excellent interpersonal and communication skills with the ability to work effectively in a team-oriented environment.
• Strong organizational and project management skills with the ability to prioritize and manage multiple tasks simultaneously.
• Proficient in MS Office applications and information regulatory information management software (e.g., eCTD, Veeva).
• Proficient in written and spoken English.