Regulatory Affairs Manager, Sea
2 weeks ago
Today, Lonza is one of the world’s largest healthcare manufacturing organizations operating across five 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 position is responsible to capture and surveil regulatory requirements for Lonza’s Health Ingredients (CHI) division covering the nutraceuticals (incl pets) market in Southeast Asia (SEA) and local requirements for the pharmaceuticals market in Thailand, including import/export requirements.
The role is our main SEA point of contact for regulatory support of Health Ingredients and Dosage Form Solutions for external and internal customers (Commercial/R&D/Marketing/Quality), and to leverage regulatory compliance as a business value. Role will also contribute & sustain market recognition as a compliant business partner in a regulated environment.
**Key responsibilities**:
- Monitor applicable regulations or guidelines and translate into comprehensive action plans to ensure compliance of the product portfolio in scope. Develop and maintain systems for proper implementation with internal stakeholders.
- Manage customer and authority requests related to regulatory and compliance with the aim to increase customer delight and to ensure compliance.
- Collaborate with company internal network to obtain necessary product documentation (e.g. from global production sites outside SEA) in support of local regulatory projects and customer requests.
- Support Marketing, R&D and Business Development in ad hoc projects, in relation to market growth and innovation initiatives by preparing SEA regulatory assessments for relevant regulatory topics of interest, and through review of Marketing Communication materials for SEA countries with regard to local regulatory compliance.
- Support Logistics by determining the regulatory requirements related to export / import of the product portfolio in scope from and to the SEA region. Where needed, liaise with local and foreign authorities to come to an agreement for the correct export / import certificate.
- Support sales by ensuring regulatory assessment for compliant marketing of Dosage Form Solution products in the SEA region such as determining appropriate regulatory and quality standards for the intended use.
- Support collaboration with Halal authorities and certification bodies in Thailand to ensure solutions for market requirements and to maintain required certifications.
- Where relevant, participate to value adding industry conferences as well as required external and internal regulatory expert networks or trade associations in the SEA region.
- Perform other duties that are aligned with the incumbent’s skills, experience and competencies as assigned. These other duties cannot compromise the employee’s wellbeing and workload.
**Key requirements**:
- Bachelor Degree in Chemical or Food Science.
- Substantial years of relevant experience working in a Multi-National environment.
- Work experience from the Health, Food supplement industry.
- Hands-on RA experience with good understanding of local registration requirements and the related safety issues.
- Good understanding of the local culture, government bodies/ agencies and the ability to gather key market intelligence & advocate.
- Proven track record in providing recommendations to resolve registration challenges.
- Excellent business partnering skills and proven track record in supporting Sales team.
- Self-starter who is able to work across functions, regions and with excellent communication skills.
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.
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