Senior Director, Regulatory Affairs

Belgium, BornemToday, 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.

We are pleased to share details of an exciting opportunity within our Regulatory Affairs function that has arisen due to an internal promotion, further demonstrating Lonza’s commitment to the career development of its employees.

As Senior Director you will assume global responsibility for all regulatory affairs activities across the CHI business unit, inclusive of Hard Capsules, CHN ingredients and finished CHN products.

**Key responsibilities**:

- Responsible for developing the global regulatory affairs strategy for CHI and execution of the CHI objectives.
- Oversees the evaluation and analysis of the impact of trends relative to government regulatory activities on a global basis. Ensures that requirements are translated into comprehensive action plans and properly implemented within the business unit globally.
- Fosters an innovative culture (sharing best practices) - interaction with business unit and customers along with exploration and evaluation of new business opportunities.
- Ensures collaboration with regulatory bodies to gain product approvals and find solutions for market requirements
- Ensures presence in external and internal regulatory expert networks, to anticipate and identify applicable regulatory evolutions in the domain of excipient, pharmaceutical, ingredient and food manufacturing
- Maintains relevant documentation as part of the quality systems and regulatory requirements
- Functions as strategic enabler for BU strategies and oversees RA deliverables in BU operations plans

**Key requirements**:

- Considered an SME for all Regulatory Affairs matters within CHI
- Able to influence and deliver strategic based discussions at Executive level
- Strong people management and leadership skills with a proven track record of leading highly successful and large teams
- High level of regulatory acumen
- Proven experience liaising and interacting with trade organisations that will ultimately influence the shaping of regulatory frameworks
- Experience of working closely and engaging with Health Authorities

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: R51776**: