Regulatory Affairs Consultant
hace 8 horas
We are currently recruiting for two Regulatory Affairs Consultant / Leads roles, one located in Mexico and the other located multi-country (Argentina o Peru or Brazil). As Regulatory Affairs Consultant / Leads, these individuals will play a pivotal role in supporting our global strategies and ensuring compliance with local regulations in their respective regions.
Skills and experience:
- More than 06 years in the Clinical Trial Regulatory Area.
- Having experience in leading projects at the global regulatory level.
- Having experience leading the regulatory team and coordinating the compilation of the Core dossiers to be submitted by the SMEs to several countries worldwide from end to end.
- Experience in Central America countries will be value, but it's not mandatory.
- Knowledge of EU-CTR 536/2014 (ideal).
- Coordinate and manage the flow of information, track project progress, and identify and solve problems in a team-oriented environment.
- Interface with the project team and the regulatory authorities on regulatory and technical matters, as appropriate.
- Support the sponsor for the development of optimized clinical trial submission strategies.
- Project management knowledge.
- Advanced written and Speaking English.
- Client-focused approach to work.
- Results orientation.
- Teamwork and collaboration skills Consulting skills.
- Excellent interpersonal and intercultural communication skills, both written and verbal.
- Critical thinking and problem-solving skills.
- Proficiency in the local language.
LI-REMOTE
-
Regulatory Affairs Consultant
hace 4 semanas
Ciudad de México Parexel A tiempo completoWe are currently recruiting for two Regulatory Affairs Consultant / Leads roles, one located in Mexico and the other located multi-country (Argentina o Peru or Brazil). As Regulatory Affairs Consultant / Leads, these individuals will play a pivotal role in supporting our global strategies and ensuring compliance with local regulations in their respective...
-
Sr. Regulatory Affairs Associate- CONSULTANT
hace 1 semana
Ciudad de México, Ciudad de México ClinChoice A tiempo completoAre you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….ClinChoice is searching for a Sr. Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our...
-
Regulatory Affairs Associate
hace 1 semana
Ciudad de México, Ciudad de México ClinChoice A tiempo completoAre you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our...
-
CMC Regulatory Affairs Profesionals
hace 12 horas
Ciudad de México, Ciudad de México Parexel A tiempo completoWhen our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...
-
Regulatory Affairs Head
hace 1 semana
Ciudad de México, Ciudad de México Johnson & Johnson Innovative Medicine A tiempo completoAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...
-
Regulatory Affairs Head
hace 1 semana
Ciudad de México, Ciudad de México Johnson & Johnson A tiempo completoAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...
-
Regulatory Affairs Head
hace 1 semana
Ciudad de México, Ciudad de México Johnson & Johnson Innovative Medicine A tiempo completoAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...
-
Regulatory Affairs Coordinator
hace 1 semana
Ciudad de México Novo Nordisk A tiempo completoRegulatory Affairs Coordinator**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Ciudad de México, Ciudad de México, MX- Regulatory Affairs Department- Mexico City, Mexico**Your new role**- As a Regulatory Affairs Coordinator, you will:- Ensure that Novo Nordisk’s portfolio has all necessary COFEPRIS authorisations to be sold in Mexico.-...
-
Analyst, Regulatory Affairs
hace 8 horas
Ciudad de México Olympus Corporation of the Americas A tiempo completo**Ubicación MEXICO, MEXICO CITY**¿Está buscando una empresa que se preocupe por la vida y la salud de las personas, incluida la suya? Inspiremos vidas más saludables, juntos**Olympus, una empresa líder en tecnología médica, se ha centrado en mejorar la vida de las personas durante más de 100 años.****Nuestro propósito es hacer que la vida de las...
-
Regulatory Affairs Manager
hace 4 semanas
Ciudad de México Elemental Enzymes A tiempo completo**Regulatory Affairs Manager - LATAM**Elemental Enzymes (EE) is looking for a Regulatory Affairs Manager to develop regulatory strategy, manage regulatory submissions and maintain regulatory compliance for EE products in the Central and South American countries. Products include biopesticides, biostimulants, and biofertilizers. This position will report to...