Section Manager, Regulatory Affairs
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.
This is an exciting role for our Cell & Gene Therapy business, the Section Manager Regulatory Affairs will support clinical trial and product license applications for our customers. Role will work collaboratively with inter-company personnel to co-ordinate the regulatory activities for clinical development, product license applications as well as life cycle management.
- Frontline advisor for regulatory issues to customers and internal SMEs
- Service provider for regulatory filings to customers
- Regional, Asian-Pacific (APAC), analyzer and contributor for regulatory intelligence to Lonza Regulatory Affairs (RA) network
- Contact point for regulatory affairs to regulatory authorities.
Key Accountabilities and Duties:
- Customer Supports: including regulatory technical writing, regulatory filing, and regulatory authority communications
- Internal Supports: including regulatory assessments and consultation services
- RA Network Supports: Supporting activities initiated/ managed by LPB Regulatory Affair network.
- Degree in Life Sciences in Chemistry/ Biology/ Biochemistry/ Pharmacy or Equivalent
- Significant years of pharmaceutical industry experience
- Experience of preparing, authorizing or submission of IND/IMPD, NDA/BLA for biologics is preferable
- Working knowledge of APAC, US or EU regulatory requirements for biologics is preferable
- Excellent organizational skills and attention to details
- Excellent communication and interpersonal skills
- Team player and ability to work well with cross functional teams.
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 achieve 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.