Regulatory Affairs Specialist - GCO-00000U0S
Description
“Las Compañías de Johnson & Johnson ofrecen a todos los candidatos igualdad de oportunidades de empleo”
.
The Global Job Posting policy promotes the commitment to the advancement and development of our employees. We invite you to read this posting and apply if you are interested in the position and meet the requirements.
Company description:
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time. Our people, across many different companies, are united in their passionate pursuit of science for the benefit of patients. With employees in over 50 countries, we share the commitment of our corporate parents to bring innovative ideas, products and services to patients throughout the world.
Searching the best talent for: Regulatory Affairs Specialist
Band: 25
General description:
Provide support to GCO Clinical Trials Mexico in obtaining documents and submission of all regulatory proceedings with Regulatory Authorities and Ethics Committees, in order to achieve on time protocol approvals and import/export licenses for materials used in Local/Corporate trials .
Coordinates start up phase of clinical trials in Mexico, ensuring continuity and compliance with timelines with the central study teams
Assures compliance with all the applicable regulations through the complete duration of the trials.
Functions:
- Ensures Ethic Committees and Health Authorities submissions (Protocol, Ammendments, Importation licenses),are performed according to established timelines and proper follow up is given until approval is granted
- Liaison with corporate, customs, brokers and local internal departments to obtain information which allows to prepare regulatory files and submissions with EC and MOH,
- Cooperates with Clinical Supply Chain Team to guarantee timely import of all materials for clinical trials and its corresponding customs clearance
- Internally coordinates Pharmacovigilance activities, ensuring that the local regulations are followed
- Collaborates with LSO / LSD for the reconciliation of safety reports of clinical trials to Health Authorities where required by local regulations
- Prepares, analyzes and submits technical-legal Dossiers to COFEPRIS and other government entities according to local and corporate regulatory requirements.
- Guarantees the authorization of research protocols and import/export licenses for all the supplies required for the development of the study, allowing the continuity of international studies the support the scientific information about the research and development of new products.
- Ensure regulatory database is up to date.
- Contact point of Global Regulatory Affairs for Mexico and Central America regarding clinical research, providing all the information necessary for the implementation and conduction of clinical studies.
- Coordinates and supervises the activities of the ad hoc start up team
- Generate and implement SOPs
- Participates in global projects for regulatory improvement
- Identifies opportunity areas and proposes plans for teamwork.
- Optimizes resources for regulatory and clinical research studies (CTAs).
Calificaciones
Qualifications
A minimum of a BA/BS degree is required (Chemist,Physician, Admin, related to the pharmacy industry).
A minimum of 3 years experience on regulatory activities and Import/Export activities, preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations.
Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
Proficient in speaking and writing the country language and English. Good written and oral communication skills
Ubicación principal: America Latina-México-Distrito Federal-Ciudad de México
Organización: Janssen de México, S. de R.L. de C.V. (7250)
Área: Regulatory Affairs
Description
“Las Compañías de Johnson & Johnson ofrecen a todos los candidatos igualdad de oportunidades de empleo”
.
The Global Job Posting policy promotes the commitment to the advancement and development of our employees. We invite you to read this posting and apply if you are interested in the position and meet the requirements.
Company description:
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time. Our people, across many different companies, are united in their passionate pursuit of science for the benefit of patients. With employees in over 50 countries, we share the commitment of our corporate parents to bring innovative ideas, products and services to patients throughout the world.
Searching the best talent for: Regulatory Affairs Specialist
Band: 25
General description:
Provide support to GCO Clinical Trials Mexico in obtaining documents and submission of all regulatory proceedings with Regulatory Authorities and Ethics Committees, in order to achieve on time protocol approvals and import/export licenses for materials used in Local/Corporate trials .
Coordinates start up phase of clinical trials in Mexico, ensuring continuity and compliance with timelines with the central study teams
Assures compliance with all the applicable regulations through the complete duration of the trials.
Functions:
- Ensures Ethic Committees and Health Authorities submissions (Protocol, Ammendments, Importation licenses),are performed according to established timelines and proper follow up is given until approval is granted
- Liaison with corporate, customs, brokers and local internal departments to obtain information which allows to prepare regulatory files and submissions with EC and MOH,
- Cooperates with Clinical Supply Chain Team to guarantee timely import of all materials for clinical trials and its corresponding customs clearance
- Internally coordinates Pharmacovigilance activities, ensuring that the local regulations are followed
- Collaborates with LSO / LSD for the reconciliation of safety reports of clinical trials to Health Authorities where required by local regulations
- Prepares, analyzes and submits technical-legal Dossiers to COFEPRIS and other government entities according to local and corporate regulatory requirements.
- Guarantees the authorization of research protocols and import/export licenses for all the supplies required for the development of the study, allowing the continuity of international studies the support the scientific information about the research and development of new products.
- Ensure regulatory database is up to date.
- Contact point of Global Regulatory Affairs for Mexico and Central America regarding clinical research, providing all the information necessary for the implementation and conduction of clinical studies.
- Coordinates and supervises the activities of the ad hoc start up team
- Generate and implement SOPs
- Participates in global projects for regulatory improvement
- Identifies opportunity areas and proposes plans for teamwork.
- Optimizes resources for regulatory and clinical research studies (CTAs).
Calificaciones
Qualifications
A minimum of a BA/BS degree is required (Chemist,Physician, Admin, related to the pharmacy industry).
A minimum of 3 years experience on regulatory activities and Import/Export activities, preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations.
Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
Proficient in speaking and writing the country language and English. Good written and oral communication skills
Ubicación principal: America Latina-México-Distrito Federal-Ciudad de México
Organización: Janssen de México, S. de R.L. de C.V. (7250)
Área: Regulatory Affairs