Senior Regulatory Affairs Specialist

United States, Portsmouth (New Hampshire)

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 Senior Regulatory Affairs Specialist will support CMC project activities for customers and the Portsmouth site.  Working collaboratively with company personnel, the Senior Regulatory Affairs Specialist will execute routine Regulatory Conformance activities (change controls, deviations, vendor change notifications), coordinate the regulatory CMC activities for development and commercial programs, provide regulatory support and advice for the Portsmouth site, and support the authoring of site-specific regulatory documents.

Key Responsibilities:

  • Review change controls, deviations, and vendor change notifications for regulatory impact per established procedures

  • Attend customer, department, and project team meetings

  • Construct and maintain regulatory project plans in line with best practice recommendations

  • Update functional leads and maintain transparency of information across regulatory function

  • Maintain site manufacturing licenses, perform Establishment Registration and Product Listing as required

  • Maintain the Portsmouth Site Master File per established procedures

  • Support customer Rest of World submissions by providing required cGMP plant documentation

  • Provide regulatory support and advice for external customers in line with defined Regulatory plans and in response to ad-hoc questions

  • Write / review CMC sections and prepare briefing documents for agency meetings, as needed

Key Requirements:

  • Bachelor’s Degree required, Masters preferred; preferred area of study, Chemistry, Biology, Biochemistry, Pharmacy or similar

  • Working experience in the pharmaceutical industry, with experience in a Regulatory Affairs and/or preparing and authoring CMC sections for late phase applications and license applications

  • Understanding of biologics work processes.

  • Ability to interpret compliance requirements for the creation or review of protocols and site documentation. .

  • Proficient with Microsoft Office products

  • Superb organizational skills and attention to detail

  • Demonstrated ability to manage priorities and work under tight timelines

  • Uses knowledge of their business area and related areas to make correct and timely decisions

  • 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.

  • 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.

Reference: R31343