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 Affairs CMC Manager II will support the site and customer related regulatory affairs and CMC project activities. Work collaboratively with appropriate company personnel to coordinate the regulatory work stream elements for CMC activities for Portsmouth Lonza Pharma and Biotech customers. Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions.
Must be within (or able to relocate to) commuting range of our Portsmouth NH facility, as regular on-site presence is required for this role
Key Responsibilities:

• Preparation and/or review of scientific and technical information suitable for Health Authority submission in conformance with applicable Lonza procedures.
• Lead the submission preparation and/or review of customer clinical (e.g IMPD/INDs) and commercial (e.g. MAA/BLAs) filings.
• 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 documents for customer RoW submissions including certifications and attestations where applicable.
• Internal regulatory support for operation and control, including Interpretation of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of Mammalian products. Maintain transparency of information across regulatory function.
• Site support for deviation and change control assessment for regulatory impact. Support site-specific regulatory documentation and activities.
• Maintenance of Lonza site Facility registrations with regulatory agencies and plant-level documentation (e.g. Site Master File and Japan FMA).
• Lead the creation and maintenance of Lonza Drug Master Files as appropriate for site activities.
• The individual in this role is an individual contributor and will not have any direct supervisory responsibilities.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, and cGMP regulations.

Key Requirements:

• Bachelor's Degree or higher required in applicable science field or equivalent
• Regulatory Affairs Certification (RAC) Preferred
• 10 years of experience working in Pharmaceutical/ Biotechnology or related industries
• Minimum 7 years of experience preparing/authoring CMC DS sections for IMPD, IND, BLA
• Experience with module 32S and 32P
• Familiarity with the contents of the CMC dossier and related guidances
• Project management experience
• Computer software skills (LIMS, SAP, TrackWise, Veeva will be used)
• Organizational and time management skills including record keeping and planning skills
• Ability to interact with internal and external customers regularly, working in a global environment across time zones

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.