CMC Strategist / Senior Manager Regulatory Affairs-CMC Documentation

Smartedge Solutions; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading consultancy in regulatory affairs is looking for a CMC Strategist/Senior Manager to support compliance documentation. This remote role involves managing the execution of CMC documentation, collaborating with various teams, and ensuring adherence to regulatory standards. Ideal candidates will have substantial experience in CMC compliance activities and a deep understanding of regulatory processes to assure seamless product supply continuity. If interested, please reach out to discuss further details.

Formación

• Experience in CMC documentation management.
• Ability to collaborate with regulatory teams.
• Familiarity with regulatory guidelines.

Responsabilidades

• Provide support in compiling CMC documentation.
• Lead regulatory strategy development.
• Manage execution of CMC documentation.

Conocimientos

CMC compliance activities

Gap Analysis

Regulatory documentation

Collaboration

Descripción del empleo

Smartedge’s Client is looking for an individual to help with their

CMC Strategist / Senior Manager Regulatory Affairs-CMC Documentation @ Spain (100 % Remote Working)

Key Area

Provide support in compiling and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation.

Coordinate with manufacturing and quality teams to ensure accurate and timely data for regulatory submissions.

Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports

Experienced in authoring assessment reports and Part2 / Expert reports for Dossiers

Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.

Collaborate with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.

Manage execution / authoring of CMC documentation (Module 1, 2 and 3) for life cycle management - post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.

Knowledge of regulatory guidelines and relevant applications.

Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.

If this sounds like a role you would be interested in or if you know someone in this field.

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