Senior Manager Global Regulatory Affairs CMC

Stellenbeschreibung

We have an exciting opportunity for a Senior Manager Global Regulatory Affairs CMC to join our team. The GRA CMC senior manager will have a technical strategic role within the GRA Chemistry Manufacturing and Controls (CMC) Group. The role will collaborate globally with internal and external stakeholders and will support the global registration of novel biologic therapies in the cardiovascular and metabolic therapeutic area.

Role and Responsibilities

• Support the development and implementation of the global CMC regulatory strategy for Biologics in the Cardiovascular and metabolic therapeutic area through all development phases to registration and post approval lifecycle stages.
• Author, prepare, and compile high quality, submission-ready CMC documentation for HA submissions.
• Plan and contribute to preparation activities for Biologics License Application (BLA) and preparation of briefing books.
• Collaborate globally with internal and external stakeholders (including R&D and Quality) and represent GRA CMC in cross-functional project teams.
• Ensure compliance of CMC regulatory dossiers with manufacturing and quality control processes
• Ensure CMC dossiers meet content requirements for applicable territories in collaboration with regional colleagues.
• Support global CMC regulatory policies and procedures.

Your Skills and Experience

• University degree in natural sciences (MS or equivalent), a Ph.D. or further degree, e.g., in Regulatory Affairs is advantageous.
• 7+ years regulatory experience in the pharmaceutical industry. Biologics Regulatory experience preferred.
• Sound technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, CH, or 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, management, and senior management.
• Ability to work with minimal supervision, with sound technical judgment and analytical skills.
• Flexibility to work in a global cross cultural work environment and can work independently as well as in a team.
• Fluent in English

We are looking forward to receiving your online application including your CV and cover letter.

About Us

Our Benefits

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CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

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