Associate Director CMC Regulatory Affairs

3 weeks ago

Hayward, United States Lonza Group Ltd. Full time
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 coordinate 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:

  1. Mentor, coach, and lead direct reports, including 1:1 meetings, performance appraisals, objectives, and development planning.
  2. Lead recruitment of employees to the regulatory function.
  3. Identify RA resources to support site’s regulatory needs (capacity and demand forecasting, financial reporting).
  4. 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.
  5. 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.
  6. 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.
  7. Internal regulatory support for operation and control (e.g., 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).
  8. Support for site inspections and audits, improvement and development, expansion projects.
  9. 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.
  10. 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.
  11. Perform other duties as assigned.

Key Requirements:

  1. Bachelor's degree in Life Science.
  2. Regulatory Affairs Certification (RAC) or equivalent issued by the Regulatory Affairs Professional Society or equivalent preferred.
  3. Extensive experience in the Pharmaceutical or Biotech industry.
  4. Advanced regulatory CMC experience in managing complex biotechnology dossier programs, complex regulatory projects (facility changes, regulatory intelligence, CMC submission strategy).
  5. Computer software skills.
  6. Organization skills.
  7. Record keeping and planning skills.
  8. Training skills.
  9. Time management.
  10. Facilitation skills.
  11. Professional attitude.
  12. Coaching, mentoring, and line manager skills.
  13. 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) days.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

The full-time base annual salary for this position is expected to range between $185,400.00 and $260,000.00. Compensation for the role will depend on a number of factors, including the successful candidate’s qualifications, skills, competencies, experience, and job-related knowledge. Full-time employees receive a comprehensive benefits package including performance-related bonus, medical and dental coverage, 401k plan, life insurance, short-term and long-term disability insurance, an employee assistance program, paid time off (PTO), and more.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

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