Head of Regulatory Affairs

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.

Reporting to the Head of Regulatory Affairs for Biologics & Licensing and based at Portsmouth, the Head of Regulatory Affairs will support the site and customer related regulatory affairs and CMC project activities. In this role you will work collaboratively with appropriate company personnel to coordinate the regulatory work stream elements for CMC activities for Portsmouth Lonza Pharma and Biotech products (mammalian fermentation).

Key responsibilities:

  • Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions. This will include: preparation and review of scientific and technical information, drafting of IMPD/INDs and MAA/BLAs for customers, support for scientific advice meetings and development of regulatory strategy with customers, RoW submission support
  • Management of the Portsmouth regulatory team covering biologic functions.
  • Internal regulatory support for the site operation and control eg:Interpretation of EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of biological products.
  • Function as the regulatory contact in all direct communication with regulatory agencies.
  • Support site specific regulatory documents and activities
  • Update functional leads and maintain transparency of information across regulatory function.
  • Regulatory support for deviation and change control activities, as appropriate

Key requirements:

  • Bachelor's degree required, advanced degree desired. Preferred area of study in life sciences.
  • Significant experience in bio-pharmaceutical industry with relevant regulatory affairs experience (eg antibodies, cell therapy, gene therapy).
  • Understanding of biologics manufacturing 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 including awareness of Health Authority 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
  • 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.
  • Able to communicate a site regulatory compliance philosophy internally and to clients.
  • Experience managing others required.
  • Excellent communication and interpersonal skills
  • Demonstrated ability to work well with cross functional teams.
  • Fluent in English
  • Willingness to travel

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. 

Reference: R32355