Specialist, Regulatory Affairs
Singapore, Tuas Singapore

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.

Did you know that we are the 1st biologics contract manufacturer in Singapore? We offer you exposure to upcoming biotech and established pharmaceutical companies and to the manufacturing technology needed to produce mammalian treatments and cell therapies of tomorrow. Our global manufacturing network is recognized for its reliable, high-quality services, regulatory track record, global footprint, innovative technology platforms and extensive experience – we, in Singapore are proud to be part of this global network.

As a Regulatory Specialist you will be assist the line managers of Lonza Biologics and Lonza Bio Science in all RA support Services and also assist in assessment of deviation and change control activities.

Key Responsibilities:

  • Lead and provide regulatory support under the supervision of Line Manager for clinical trial and product license applications in line with major services agreement (MSA) or statement of work (SOW) including but not limited to the preparation of regulatory filings.

  • Provide administrative support for all necessary maintenance of certificates, licenses and drug master file(s) (DMF(s))

  • Maintain RA owned standard operating procedures (SOP) in line with the good manufacturing practice (GMP)

  • Perform regulatory assessment and impact of change control activities.

  • Provide regulatory support to project teams.

  • Participate in cross functional team to ensure regulatory documentation meets defined timelines and requirements.

  • Work in liaison with regulatory colleagues within the Lonza network to support customers clinical trial and product license application to support multi-site products.

  • Any other duties as assigned by Line Manager

Key Requirements:

  • Degree in Life Sciences in Chemistry / Biology / Biochemistry / Pharmacy or equivalent with 2-5 years of Industry knowledge.

  • Knowledge of US, EU and major international regulatory requirements (e.g WHO, ICH) for biologicals

  • Good communication and interpersonal skills

  • Ability to work with cross functional teams and work under tight timelines.

  • Enthusiastic and self-driven

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.

Reference: R58520