Regulatory Affairs, Project Manager

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 Regulatory Affairs CMC Project Manager will support the site and customer related regulatory affairs and CMC project activities.

Key Responsibilities:

  • 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.
  • Preparation and/or review of scientific and technical information suitable for Health Authority submission in conformance with applicable Lonza procedures. 
  • Preparation and/or review of customer clinical (e.g IMPD/INDs) and commercial (e.g.MAA/BLAs) submissions.
  • 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 source documents for customer RoW submissions including certifications and attestations where applicable.
  • Internal regulatory support for operation and control
  • Regulatory support for deviations, change controls, VCNs, Pre-Campaign activities and other project team support, as required.
  • Maintenance of Lonza LBP and CGT site Facility registrations with regulatory agencies and plant-level documentation (e.g. Site Master File).

Key requirements:

  • Substantial experience in the bio-pharmaceutical industry experience with a doctorate degree or significant experience plus years of experience with a Bachelor's degree of which at least intermediate level relevant regulatory affairs experience (eg antibodies).
  • 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
  • Sets and delivers on objectives for themselves (and their team) that support the company strategy
  • Strategic approach and system oriented toward goals and objectives.
  • Ability to represent the company on regulatory issues both internally and externally.
  • Strong interpersonal skills and ability to interact positively with all functions
  • 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 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: R31357
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