Project Manager, Regulatory Affairs
United States, Portsmouth (New Hampshire)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 Regulatory Affairs Project Manager will support the site and customer related regulatory affairs and CMC (Chemistry, Manufacturing and Controls) project activities.
- Work collaboratively with appropriate company personnel to co-ordinate the regulatory work stream elements for CMC activities for Portsmouth Lonza Pharma and Biotech customer.
- Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions.
- Significant experience in the bio-pharmaceutical industry experience with a Bachelor's degree of which at least intermediate level relevant regulatory affairs experience (eg antibodies), advanced degrees preferred.
- Understanding of biologics work processes.
- Expertise in the interpretation and communication of CMC regulatory requirements for site product and process issues.
- Working knowledge of US and EU regulatory requirements for biologicals.
- Ability to interpret compliance requirements for the creation or review of protocols and site documentation.
- Agencies and Industry trends across all areas of GXP to anticipate the needs of both the company and the customers and communication of these trends.
- Proven experience of preparing and authoring IND (Investigational New Drug), NDA/BLA (New Drug Application or a Biologics License Application), and CTD (common technical document) submissions for biological products
- Proficient with Microsoft Office products
- Superb organizational skills and attention to detail
- Demonstrated ability to manage priorities and work under tight timelines
- Sets and delivers on objectives for themselves (and their team) that support the company strategy
- Uses knowledge of their business area and related areas to make correct and timely decisions and to identify and develop operational/financial improvements
- Able to work in a diverse environment to obtain solutions based on a solid background and understanding of the company procedures, regulatory guidance, current legislation and company objectives.
- Ability to review and critique complex technical documents.
- Strong influencing skills.
- Strategic approach and system oriented toward goals and objectives.
- Ability to represent the company on regulatory issues both internally and externally.
- Strong written and verbal communication; ability to present to various audiences’ levels.
- Able to communicate a site regulatory compliance philosophy internally and to clients.
- Fluent in English
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 it is 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.