GRA CMC Specialist

CSL•Waltham, MA

About The Position

GRA CMC Manager to lead strategic and operational CMC regulatory activities across product development, clinical submissions, registrations, and lifecycle management. In this role, you will shape global CMC regulatory strategy, ensure compliant execution of submissions and changes, and partner with technical and regulatory teams worldwide. Responsible for operational CMC regulatory activities related to the assigned products and/or intermediates, including as applicable: Maintenance of the content of relevant parts of the regulatory dossiers. Preparation, revision and review of Module 2.3, Module 3, required facility and equipment information and related documents for new product registrations (e.g. MAAs, BLAs) and life cycle submissions according to agreed timelines and taking regional regulatory requirements into account. This may include technical authoring of dossier narratives and other regulatory CMC documentation. Timely provision of high-quality responses to CMC related Health Authority questions. Compilation and review of CMC information for CTAs, INDs and other regulatory submissions related to product development (e.g. CMC documentation for Scientific Advice Meetings, Briefing Books, IBs). Provision or support of timely and compliant regulatory assessments as well as efficient execution of CMC changes. Preparation and review of CMC related information and documentation required for tenders, PSURs, DSURs, CCDS/product information and promotional materials. Regulatory contribution to annual product quality reviews and risk assessments. Responsible for strategic CMC regulatory activities related to the assigned products and/or intermediates, including as applicable: Is a permanent member of the Global Regulatory Affairs Strategy Team(s) (GRAST(s)) and/or of relevant CMC Regulatory Sub-Team(s). May represent Global Regulatory Affairs in Project Teams for CMC projects. Is responsible for development and implementation of global CMC regulatory strategies for product development, clinical trial applications, new license applications, product changes and relevant CMC projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements. Is the primary GRA contact point interfacing with relevant technical expert departments for project planning purposes, compilation and updates of technical documentation and for addressing CMC regulatory questions. Evaluates the available technical and scientific CMC information for compliance with regulatory requirements, performs gap analysis and proposes solutions and strategies to remediate risks. Supports scheduling and prioritization of CMC related submissions.

Requirements

University degree in natural sciences (BS/BA/MS or equivalent), a degree in Regulatory Affairs is advantageous.
Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 3 years in Regulatory Affairs.
Sound knowledge in natural sciences with a focus on biological medicinal products.
Basic knowledge of the regulatory framework in at least one key region (US, EU, Japan, CH, Australia).
Excellent communication, project management, planning, problem solving and presentation skills.
Strong team player with a demonstrated ability to develop constructive and effective relationships with peers and management.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to work with minimal supervision based on sound technical and analytical judgment.
Flexibility to work in a global cross-cultural work environment.
Microsoft Office skills.
Fluent in English and local language.

Responsibilities

Drive global CMC strategies for clinical trial applications, new product licenses, and post-approval changes.
Assess CMC, facility/equipment, and plasma-related changes and manage regulatory submissions in coordination with regional teams.
Serve as primary regulatory liaison with technical experts; support GMP inspections and inspection readiness.
Interpret regulatory guidelines and requirements; prepare impact assessments and contribute to process improvements.
Provide technical guidance to CMC Scientists; may deputize for the CMC Team Lead.
Maintenance of the content of relevant parts of the regulatory dossiers.
Preparation, revision and review of Module 2.3, Module 3, required facility and equipment information and related documents for new product registrations (e.g. MAAs, BLAs) and life cycle submissions according to agreed timelines and taking regional regulatory requirements into account. This may include technical authoring of dossier narratives and other regulatory CMC documentation.
Timely provision of high-quality responses to CMC related Health Authority questions.
Compilation and review of CMC information for CTAs, INDs and other regulatory submissions related to product development (e.g. CMC documentation for Scientific Advice Meetings, Briefing Books, IBs).
Provision or support of timely and compliant regulatory assessments as well as efficient execution of CMC changes.
Preparation and review of CMC related information and documentation required for tenders, PSURs, DSURs, CCDS/product information and promotional materials.
Regulatory contribution to annual product quality reviews and risk assessments.
Is a permanent member of the Global Regulatory Affairs Strategy Team(s) (GRAST(s)) and/or of relevant CMC Regulatory Sub-Team(s).
May represent Global Regulatory Affairs in Project Teams for CMC projects.
Is responsible for development and implementation of global CMC regulatory strategies for product development, clinical trial applications, new license applications, product changes and relevant CMC projects with a view to reach approvals in the most efficient way while ensuring compliance with global regulatory requirements.
Is the primary GRA contact point interfacing with relevant technical expert departments for project planning purposes, compilation and updates of technical documentation and for addressing CMC regulatory questions.
Evaluates the available technical and scientific CMC information for compliance with regulatory requirements, performs gap analysis and proposes solutions and strategies to remediate risks.
Supports scheduling and prioritization of CMC related submissions.