Regulatory Specialist

Há 3 dias

Rio de Janeiro, Brasil Lonza Tempo inteiro

Brazil, Rio De JaneiroToday, 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.

**Key responsibilities**:

- Work with the consultant for the Register/ Revalidation of Finished Goods and Ingredients ANVISA and MAPA as applicable to the CHI business.
- Responsible for monitoring regulatory and compendial changes that impact the business and aiding in action plan development.
- Capture applicable regulatory evolutions, documented via a pragmatic impact assessment and centralized in an overview database, in the applicable domains of CHI products and overall GMP requirements.
- Actively support customers and authority requests with the aim to increase Customer Satisfaction and regulatory compliance, via maintaining standard customer statements, supporting partnership programs and agreements with strategic and business-relevant customers, and presence at customers for technical or regulatory support where needed.
- Support marketing, BD, R&D, and Lonza BU in ad hoc projects, in relation to market growth and innovation initiatives by preparing South America regulatory assessments for relevant regulatory topics of interest.
- Responsible for communication with Trend Associations such as SINDUSFARMA, ABIAD, and ABIFISA.
- Regulatory support for customers in South America.
- Approval and Revalidation of local licenses - CRF; MAPA, Local Sanitary Vigilance.
- Work with the consultant on products’ adequacy according to current legislation including Capsules, DFS Products and Ingredients in Human and Animal Health.

**Key requirements**:

- Bachelor's degree in Pharmacy, Regulatory Affairs, Biology, Chemistry, or related field.
- Pos Graduated in progress will be preferred.
- Advanced Portuguese.
- Advanced English Level (B2+, C1 level).
- Advanced Spanish Level.
- At least 4 years of experience with regulatory responsibilities in the pharmaceutical and food / dietary supplement industry for South America.
- Good Microsoft Office knowledge.

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 a disability, protected veteran status, or any other characteristic protected by law.

**Reference: R53926**:

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