Regulatory Affairs, Project Manager
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 Regulatory 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.
- The Regulatory Project Manager will support the site and customer related regulatory affairs and CMC 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.
- Preparation and/or review of scientific and technical information suitable for Health Authority submission in conformance with applicable Lonza procedures.
- Preparation and/or review of customer clinical (e.g IMPD/INDs) and commercial (e.g.MAA/BLAs) submissions.
- Preparation and/or review of responses to agency submission review questions.
- Preparation and review of customer variation submissions.
- Support for scientific advice meetings and development of regulatory strategy with customers.
- Prepare source documents for customer RoW submissions including certifications and attestations where applicable.
- Internal regulatory support for operation and control eg:
- Interpretation of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of Mammalian products.
- Support site-specific regulatory documentation and activities.
- Maintain transparency of information across regulatory function.
- Regulatory support for deviations, change controls, VCNs, Pre-Campaign activities and other project team support, as required.
- Maintenance of Lonza site Facility registrations with regulatory agencies and plant-level documentation (e.g. Site Master File).
- Perform other duties as assigned.
- Advanced years of bio-pharmaceutical industry experience with a doctorate degree or advanced plus years of experience with a Bachelor's degree of which at least intermediate level relevant regulatory affairs experience (eg antibodies).
- 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.
- Demonstrated skills managing project timelines;
- Proven experience of preparing and authoring IND, NDA/BLA, and CTD 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.
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.