Regulatory Affairs Senior Specialist-00000NQ9
Description
“Johnson & Johnson companies are equal opportunity employers”
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.
Description
Our companies of MD & D (Medical Devices & Diagnostics) provides treatment technologies in the areas of biopharmaceutical, orthopedics, spine, sports medicine and neurology, sutures and tissue repair, minimally invasive surgery, cardiovascular disease and diabetes care.
Searching the best talent for: Sr. Regulatory Affairs Specialist
Band: 26
General description:
Provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products. The individual may prepare and submit documentation needed for registration or may oversee such preparation. Also support of the product development process, submissions and regulatory compliance and assist with post-market review of product issues and other projects in domestic and international areas.
Main responsibilities:
- Prepares and/or supervises required local submissions of Biologics and Devices with minimal supervision.
- Supports regional team on product submissions schedules, prioritization and pipeline management.
- Provides assistance with Biologics establishment registration licenses.
- Coordinate information on several projects simultaneously.
- Interacts with other J&J personnel, government agencies in a professional, decisive, & articulate manner.
- Compliance Alerts support when regulatory agency report is needed.
- Selects and manages the work of different providers such as authorized third parties, translators, dossier preparation services, etc.
- Represent J&J at local Ministry of Health meetings and external organizations.
- Prepares and leads training for RA Specialists and Associates.
- Lead specific projects according local needs.
- Able to provide strategic solutions to local RA team.
- Scans the external environment.
Reports to: Regional Regulatory Affairs Manager
Qualifications
Qualifications
- A Bachelor’s Degree in Chemical/Pharmaceutical/Medical.
- 90% English language.
- Good PC skills.
- Must have 3 - 5 years experience at least working in Regulatory Environment in Pharmaceutical Companies with focus on Biologics, Blood and Vaccines.
Leadership Imperatives
- Live our Credo ~ Demonstrate and inspire the behaviours that reinforce our Credo.
- Connect ~ Develop deep insights into the needs of our patients, customers, markets and communities.
- Shape ~ Drive innovation; anticipate and shape industry and market changes to advance health care globally.
- Lead ~ Create an environment where leadership and talent development is top priority.
- Deliver ~ Deliver results by inspiring and mobilizing people and teams.
Other Competencies and skills
Results and Perfomance Driven.
Sense of Urgency.
Strategic Thinking.
Big Picture Orientation with Attention to Detail.
Intellectual Curiosity.
Relocation: and other work permissions
The Company won’t be responsable for posible relocation or permanent expenses, or work permits for this position.
Submit your resume by: March 10th
Primary Location: México
Primary Location:Latin America-Mexico-Distrito Federal-Mexico City
Organization: Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)
Job Function: Regulatory Affairs
Description
“Johnson & Johnson companies are equal opportunity employers”
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.
Description
Our companies of MD & D (Medical Devices & Diagnostics) provides treatment technologies in the areas of biopharmaceutical, orthopedics, spine, sports medicine and neurology, sutures and tissue repair, minimally invasive surgery, cardiovascular disease and diabetes care.
Searching the best talent for: Sr. Regulatory Affairs Specialist
Band: 26
General description:
Provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products. The individual may prepare and submit documentation needed for registration or may oversee such preparation. Also support of the product development process, submissions and regulatory compliance and assist with post-market review of product issues and other projects in domestic and international areas.
Main responsibilities:
- Prepares and/or supervises required local submissions of Biologics and Devices with minimal supervision.
- Supports regional team on product submissions schedules, prioritization and pipeline management.
- Provides assistance with Biologics establishment registration licenses.
- Coordinate information on several projects simultaneously.
- Interacts with other J&J personnel, government agencies in a professional, decisive, & articulate manner.
- Compliance Alerts support when regulatory agency report is needed.
- Selects and manages the work of different providers such as authorized third parties, translators, dossier preparation services, etc.
- Represent J&J at local Ministry of Health meetings and external organizations.
- Prepares and leads training for RA Specialists and Associates.
- Lead specific projects according local needs.
- Able to provide strategic solutions to local RA team.
- Scans the external environment.
Reports to: Regional Regulatory Affairs Manager
Qualifications
Qualifications
- A Bachelor’s Degree in Chemical/Pharmaceutical/Medical.
- 90% English language.
- Good PC skills.
- Must have 3 - 5 years experience at least working in Regulatory Environment in Pharmaceutical Companies with focus on Biologics, Blood and Vaccines.
Leadership Imperatives
- Live our Credo ~ Demonstrate and inspire the behaviours that reinforce our Credo.
- Connect ~ Develop deep insights into the needs of our patients, customers, markets and communities.
- Shape ~ Drive innovation; anticipate and shape industry and market changes to advance health care globally.
- Lead ~ Create an environment where leadership and talent development is top priority.
- Deliver ~ Deliver results by inspiring and mobilizing people and teams.
Other Competencies and skills
Results and Perfomance Driven.
Sense of Urgency.
Strategic Thinking.
Big Picture Orientation with Attention to Detail.
Intellectual Curiosity.
Relocation: and other work permissions
The Company won’t be responsable for posible relocation or permanent expenses, or work permits for this position.
Submit your resume by: March 10th
Primary Location: México
Primary Location:Latin America-Mexico-Distrito Federal-Mexico City
Organization: Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)
Job Function: Regulatory Affairs