Head Of Regulatory Affairs Querétaro, Mexico

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 recordsand 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.Mobile working and home office arrangements make our work routine more flexible.Food & drinksWe offer you a canteen and subsidized meals.According to the job and position, we make sure our employees get regular trainings and coaching to unleash their possibilities.Your health and well-being is important to us.

We have a company doctor and offer private medical care.TransportationWe offer organized transportation facilities for our employees.Working environmentCreating a great place to work is essential for us, so we live up to our values teamwork, responsibility, integrity, bold innovation and excellence (TRIBE).Note : Benefits might vary depending on the position.About GerresheimerGerresheimer is an innovative system and solution provider and global partner for thepharma, biotech and cosmetics industries.

The company offers a comprehensiveportfolio of pharmaceutical packaging, drug delivery systems, medical devices anddigital solutions.

Gerresheimer ensures the safe delivery and reliable administration ofdrugs to the patient.

With around 13,400 employees and over 40 production sites in16 countries in Europe, America and Asia, Gerresheimer has a global presence andproduces locally for regional markets.About GerresheimerGerresheimer is an innovative system and solution provider and global partner for thepharma, biotech and cosmetics industries.

The company offers a comprehensiveportfolio of pharmaceutical packaging, drug delivery systems, medical devices anddigital solutions.

Gerresheimer ensures the safe delivery and reliable administration ofdrugs to the patient.

With around 13,400 employees and over 40 production sites in16 countries in Europe, America and Asia, Gerresheimer has a global presence andproduces locally for regional markets.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.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.

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