Regulatory Affairs Associate
United States, Morristown (New Jersey)
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.
Lonza Morristown is hiring a Regulatory Affairs Associate to capture and surveil regulatory requirements for Lonza’s empty hard capsule (excipients) portfolio within the CHI division dedicated to the pharmaceutical market in the US. The Incumbent will collaborative with operational quality teams and install systems with the aim to ensure continued compliance.
They will also be the main point of contact for regulatory support for external and internal customers (Commercial/R&D/Marketing/Quality), and leverage regulatory compliance as business value. Sustain market recognition as a compliant business partner in a regulated environment.
- Capture applicable regulatory evolutions, documented via a pragmatic impact assessments 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.
- 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
- 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.
- Participate to relevant and value adding industry conferences as well as required external and internal regulatory expert networks or trade associations.
- Undergraduate (Science) degree in Chemistry, Bioengineering, Biotechnology ( Masters preferred)
- Strong communication skills (orally and written)
- Working experience in regulatory and Quality compliance in the healthcare industry
- Ability to write reports, business correspondence, and SOPs.
- Good in reading comprehension, critical thinking and attention to details
- Knowledge of principles and processes for providing customer services
- Data Management: Ability to locate, organize, store and back up files in a systematic fashion.
- Task Prioritization: Must be sensitive to time deadlines so that work is accomplished in the timeframes required
- Familiar with general quality management standards, GMP-rules
- Understanding of both regulatory and scientific matters.
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.