Associate Director CMC Regulatory Affairs - Vacaville, CA

Following our agreement with Roche to acquire the Vacaville manufacturing facility, we are now looking to recruit an Associate Director CMC Regulatory Affairs 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 Head of CMC Regulatory Affairs / Associate Director will lead the site Regulatory Affairs function and customer related RA CMC compliance 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. Mentor, coach and line manage direct reports.

Key Responsibilities:

• Mentor, coach and lead direct reports. including 1:1 meeting, performance appraisals, objectives and development planning.

• Lead recruitment of employees to the regulatory function

• Identify RA resources to support site’s regulatory needs (capacity and demand forecasting, financial reporting)

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

• Oversee and plan resources to represent the Lonza CMC regulatory function on customer steering team meetings, for preparation and/or review of customer clinical (e.g IMPD/INDs) and commercial (e.g. MAA/BLAs) submissions. 

• Oversee and lead the preparation of documents to support customer scientific advice meetings and development of regulatory strategy with customers.  Attendance may be required upon request of customer for Health Authority meetings.

• Internal regulatory support for operation and control eg: Review and approval of Lonza Regulatory Intelligence Bulletin, 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, expansion projects.

• Oversee regulatory support for deviations, change controls, VCNs and other project team support, site facility documentation and DMF registrations. Review and approval of quality records, dossier content, senior management review for PAI-triggering inspections.

• Strategic support for Global CMC Regulatory improvement and development of projects. Alignment of policies and procedures across Biologics sites, driving Regulatory policies or representation on site and global Biologics projects.

• 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 Society or equivalent preferred

• Extensive experience in the Pharmaceutical or Biotech industry

• Advanced regulatory CMC experience in managing  complex biotechnology dossier programs, complex regulatory projects (facility changes, regulatory intelligence, CMC submission strategy).

• Computer software skills 

• Organization skills

• Record keeping and planning skills

• Training skills

• Time management

• Facilitation skills

• Professional attitude

• Coaching, mentoring and line manager skills

• Communication skills

This position is contingent upon Lonza’s successful completion of the acquisition of the site located in Vacaville, California (the “Closing”), currently anticipated to occur in H2, 2024.  If the Closing is delayed for any reason, Lonza may delay the start date up to sixty (60) day