Regulatory Affairs Manager, Cell Therapy
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.
Based in Portsmouth, the Regulatory Affairs Manager will support the site’s and customers’ regulatory affairs and CMC project activities. This opening will reside with the expanding Cell and Gene Therapy team. The role will include providing regulatory support for the range of services Lonza provides to cell therapy customers at all stages of development including the manufacturing and testing of GMP material from clinical to commercial. In this role, you will provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc question to resolve regulatory issues.
- site-specific activities and draft and/or coordinate the review of customer regulatory clinical and commercial filings.
- Works collaboratively with appropriate company personnel for the organization and prioritization of the regulatory work and CMC regulatory activities for Portsmouth’s products and customers
- Drafts and/or reviews customer IMPD/INDs and customer MAA/BLAs
- Uses available systems and tools to coordinate and track regulatory activities
- Supports site-specific regulatory documents and activities
- Updates subject matter experts and maintain transparency of information across regulatory function
- Provides regulatory support for deviation and change control activities, as appropriate
- Interprets and evaluates regulatory data to prepare documents and submissions, as appropriate
- Provides support for scientific advice meetings and development of regulatory strategy with customers
- Interprets US, EU and other global regulatory requirements to support compliance in all phases of contract manufacturing of cell and gene therapy products
- Provides regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc question to resolve regulatory issues
- Anticipates, evaluates and implements trends and innovations in the Regulatory arena
- Significant experience in the bio-pharmaceutical industry experience with a Bachelor's degree of which at least intermediate level relevant regulatory affairs experience, advanced degrees preferred.
- Biologics experience required, cell and gene therapy highly desired.
- Expertise in the interpretation and communication of CMC regulatory requirements.
- 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), BLA (Biologics License Application) and CTD (common technical document) submissions for biological 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.
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.