Regulatory CMC Manager II - Vacaville, CA

Following our agreement with Roche to acquire the Vacaville manufacturing facility, we are now looking to recruit a Regulatory CMC Manager II for the Vacaville site!

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Regulatory Manager II will support the site and customer related regulatory affairs and CMC project activities. Work collaboratively with company personnel to co-ordinate the regulatory work stream elements for RA CMC compliance and/or RA CMC writing and review activities for Lonza Biologics Manufacturing customers. Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions.

Key Responsibilities:

• Lead and preparation and/or review of scientific and technical information suitable for Health Authority submission in conformance with applicable Lonza procedures.   

• Inform customers of Lonza’s Regulatory process for dossier preparation and completion. 

• Lead the preparation and/or review of customer clinical (e.g IMPD/INDs) and commercial (e.g. MAA/BLAs) submissions. 

• Lead the preparation and/or review of responses to agency submission review questions.  

• Lead the preparation and review of customer variation submissions. 

• Lead the preparation of documents to support customer scientific advice meetings and development of regulatory strategy with customers. 

• Lead the Preparation of source documents (facility and equipment appendices) for customer RoW submissions including certifications and attestations where applicable.

• Internal regulatory support for operation and control eg: Interpretation of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of biological products and maintain transparency of information across regulatory function.

• Support for site inspections and audits, improvement and development projects.

• Manage regulatory assessments for deviations and change controls

• Provide support for VCNs and other project team queries, as required.

• Maintenance of Lonza site Facility registrations with regulatory agencies and plant-level documentation (e.g. Site Master File and Japan FMA).

• Lead the creation and maintenance of Lonza Drug Master Files as appropriate for site activities.

• Perform other duties as assigned.

Key Requirements:

• Bachelor's degree in Life Science

• Regulatory Affairs Certification (RAC) or equivalent issued by the Regulatory Affairs Professional …