Senior CMC Consultant

An international pharmaceutical company is seeking to recruit a Senior CMC Consultant to their office in Zurich. The company focuses on the specialised therapeutic areas of oncology, neurology and immunology, fertility, and general medicine and endocrinology. This position is an exciting opportunity to work with a company that is dedicated to improving and transforming patients' lives.

Job Responsibilities:

• Providing support and report to the company's Global Regulatory CMC Lead.
• Advising on country regulatory requirements in connection with the preparation of regulatory submissions in close collaboration with company partners.
• Ensuring the compliance of GMP documentation with regulatory modules.
• Coordinating the collection of documents from site to ensure submission readiness.
• Coordinating source documents provision to ensure regulatory CMC deliverables on time, with all Site stakeholders and partners.
• Performing reviews for global CMC submissions (MAA/BLA) and responses to Health Authorities and life cycle management variations.
• Providing strategic and technical regulatory CMC expertise for new BLA/IND/IMPD/MAA applications, to support robust Module 3 Quality Sections.
• Supporting roll-out in international countries for generation of specific Module 3 Quality Sections and coordination of administrative documents.
• Ensuring aligned company regulatory input in the CMC development plan (including risk evaluation/mitigation plans).
• Reviewing critical GMP source documents (protocols and reports), in compliance with regulations, pharmacopoeia, standards, and CMC dossier strategy and plans.
• Supporting HA interaction preparation for CMC related topics (coordination of source documents and writing/review of Briefing Book).
• Ensuring regulatory compliance for all CMC dossier submissions worldwide.

Skills and Requirements:

• Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline).
• Senior Manager/Associate Director level) with a minimum of 5 years of experience in RA CMC - Biologics and a minimum of 7 years of pharmaceutical industry experience.
• Experience in preparing and managing of regulatory documentation, normally a full international submission (new product biologic application in EU/US) and large variations.
• In-depth knowledge of global pharmaceutical regulations.
• Experience in Biosimilar field would be an asset, as well as experience in in one of the following areas for biotech molecules: validation or analytical method development.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Patrick Hale at +44 203 826 1331 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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