Senior Regulatory Affairs Specialist

Join the Lonza Team

Hiring - Senior Regulatory Affairs Specialist

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.

Job Description and Requirements:

Capture applicable regulatory evolutions, documented via a pragmatic impact assessment and centralized in an overview database, in the domain of excipient and pharmaceutical products and overall GMP requirements. 

Translate applicable regulations or guidelines into comprehensive action plans and maintain systems for proper implementation with internal stakeholders. 

Maintain relevant documentation as part of the quality system and regulatory requirements. 

To centrally coordinate and maintain Lonza’s US and Health Canada excipient DMFs in current state of compliance for applicable empty capsule products and their worldwide manufacturing locations. Function as system administrator, project and SOP owner, with training system in place for relevant personnel. 

Assess applicable change requests for regulatory impact and follow-up on related regulatory action items. 

​Actively support customers and authority requests with the aim to increase Customer Satisfaction and regulatory compliance, via 

• ​Maintaining standard customer statements 

• ​Centrally manage the system for Letters of Authorization to US FDA and Health Canada empty capsule excipient Drug Master Files. 

• ​Timely providing professional and satisfactory solutions to any customer/authority request related to quality standards and regulations.  

• ​Supporting partnership programs and agreements with strategic and business relevant customers. 

• ​Presence at customers for technical or regulatory support where needed. 

​​Support marketing, R&D and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing US regulatory assessments for relevant regulatory topics of interest. 

​Support collaboration with regulatory and certification bodies to ensure solutions for marketing requirements and to maintain required certifications. 

​​Participate to relevant and value adding industry conferences as well as required external and internal regulatory expert networks or trade associations.​ 

Education Requirements:

B.S. in a Science or related discipline

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.

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.
 

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.