**Company Description**
Around 11.000 employees are working all around the globe, in production plants in 15 countries. One Gerresheimer team. Welcome to Gerresheimer. Our passion: Innovating for a better life. As a leading general partner to the pharma and healthcare industry, we stand for reliable and innovative products of the highest quality and contribute to health and well-being. Our drug delivery devices, our primary packaging in glass and plastics are being used on all continents in the pharma and cosmetics industry.
Most of all, we are an innovative and reliable employer, where you will find your professional home.
We invite you to explore our working world and your opportunities.
Ensure 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.
**Qualifications** Education**:
- 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.
**Additional Information

📌 Head of Regulatory Affairs (México)
🏢 Gerresheimer
📍 México