Regulatory Affairs, Project Manager
The Regulatory Affairs CMC 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.
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
Understands and explains the corporate strategy to their peers and/or team
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
Uses knowledge of their own business area and related areas 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.
Strong results orientation.
Ability to represent the company on regulatory issues both internally and externally.
Strong interpersonal skills and ability to interact positively with all functions
Excellent team leader as well as committed team member
Strong written and verbal communication; ability to present to various audiences’ levels.
Able to communicate a site regulatory compliance philosophy internally and to clients.
Excellent communication and interpersonal skills;.
Demonstrated ability to work well with cross functional teams.
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.