Associate Director Regulatory Affairs, CMC Integrated Biologics

Lonza; United States; Remote; USD 133,000 - 190,000; Full time

Job summary

Lonza AG is seeking an Associate Director Regulatory Affairs for their Coordinated Biologics Business Platform. The role involves providing strategic support for regulatory submissions, mentoring talent, and improving regulatory processes. This position offers a competitive salary, comprehensive benefits, and opportunities for impactful work in life sciences.

Benefits

Performance-related bonus

Medical and dental coverage

401k plan

Life insurance

Short-term and long-term disability insurance

Employee assistance program

Paid time off (PTO)

Qualifications

• 10+ years of experience in regulatory affairs.
• Strong collaboration and professional relationship skills.
• Proven experience in regulatory submissions.

Responsibilities

• Provide expert mentorship on CMC regulatory filing strategies.
• Support drafting and review of customer regulatory submissions.
• Contribute to improvement of regulatory processes.

Skills

Collaboration

Regulatory knowledge

Mentorship

Education

Bachelor’s Degree

Master’s Degree

Job description

Join Lonza AG as the Associate Director Regulatory Affairs, CMC Coordinated Biologics, an outstanding opportunity to be part of an ambitious and world-class team. You will be a pivotal player in our Coordinated Biologics Business Platform, supporting regulatory submissions and strategies on a global scale. Our ongoing growth ensures that this role is not only vital but also exceptionally rewarding!

Key responsibilities:

• Provide expert mentorship on CMC regulatory filing strategies for customer submissions across the INB Business Platform.
• Support the drafting and review of customer regulatory submissions as needed.
• Assist in developing and mentoring regulatory talent passionate about regulatory submissions and filing strategies.
• Contribute to the continuous improvement of regulatory processes and implement initiatives to streamline these processes successfully.
• Support our global Regulatory Affairs team in harmonizing efforts within the INB Regulatory team.
• Collaborate with internal collaborators to maintain credible professional relationships.
• Stay up to date on industry regulations, trends, and technologies.
• May provide backup support for Biologics site quality systems activities as needed.
• Perform other duties as assigned.

Key requirements:

• Bachelor’s Degree required, Master’s Degree preferred.
• 10+ years of related experience in regulatory affairs.
• Proven experience in regulatory submissions and strategy implementation.
• Strong ability to collaborate and maintain professional relationships.
• Outstanding knowledge of industry regulations and trends.

The full-time base annual salary for this remote position is encouraged to range between $133,000 and $189,740. Compensation for the role will depend on a number of factors, including the location of the successful candidate, 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.

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.

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.