Job DescriptionEnsure compliance with applicable national and international regulatory requirements for the company's products, processes, and services, ensuring that operations and commercialization are carried out within the applicable regulatory framework.Establish the regulatory guideline for the processes involved at Gerresheimer Querétaro.Develop and implement regulatory strategies in accordance with current national and international regulations to maintain the operations conducted at the plant.QualificationsEducation:Bachelor's degree in Chemistry, QFB (Pharmaceutical Chemist Biologist), or related field.Experience:Minimum of 1–4 years in a similar position within the pharmaceutical, medical device, or biotechnology industry.Experience handling regulatory records and regulatory audits (COFEPRIS and FDA).Knowledge of national and international standards (NOM, ISO13485, ISO15378, FDA 21 CFR part 820).Product registration processes and sterilization processes with COFEPRIS and FDA.Good Manufacturing Practices (GMP).Skills:Leadership.Teamwork and assertive communication.Analytical skills and attention to detail.Organization and ability to manage multiple projects simultaneously.About GerresheimerGerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end product. Gerresheimer achieves its ambitious goals through a high level of innovative strength, industrial competence and concentration on quality and customer focus. In developing innovative and sustainable solutions, Gerresheimer relies on a comprehensive international network with numerous innovation and production centers in Europe, America and Asia. Gerresheimer produces close to its customers worldwide with around 12,000 employees and generated annual revenues in 2023 of around EUR 2bn. With its products and solutions, Gerresheimer plays an essential role in people's health and well-being.Equal RightsWe commit to an inclusive recruitment process and equality of opportunity for all our job applicants. All applicants are considered without any regard to color, creed, religion, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership, or any other legally protected status. Preference is given to hiring people with disabilities.#J-18808-Ljbffr