HireDiversity

Ciudad de México, MX

Regulatory Affairs Specialist - (Pool of candidates)-000006TS

Description

Regulatory Affairs Specialist - (Pool of candidates)

"Johnson & Johnson companies are equal opportunity employers"

Company description:

Our companies of MD & D (Medical Devices & Diagnostics) provides treatment technologies in the areas of orthopedics, spine, sports medicine and neurology, sutures and tissue repair, biopharmaceutical, minimally invasive surgery, cardiovascular disease and diabetes care.

Searching the best talent for: Regulatory Affairs Specialist

Important: This publication has been created in order to generate pool of candidates.

General description:

Prepares proper submission for gathering market licenses as new product register, Changes and Renewals.

Supports RA Manager, to ensure submission plans on time.

Functions:
- Prepares required local submissions for New product registration, renewals & changes with a certain degree of supervision
- Follow up of other mandatory requirements for registration: local certifications, importation of samples and local testing, etc
- Represents the RA team in multifunctional projects/meetings.
- Regulatory review of promotional materials
- Prepares and approves labeling content
- Helps the work of translation and dossier contractor under the supervision of Sr. Specialist

Reports to: Regulatory Affairs Manager

Cualificaciones

· A Bachelor's Degree in Chemical/Pharmaceutical/Medical Sciences or equivalent experience.

· 75% English & local language

· Good PC skills.

· Must have 2-3 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions. Desirable experience in Medical Devices, Pharma background is acceptable

Global Leadership Profile Competencies:
- Results and Performance Driven: assumes personal ownership and accountability for business results and solutions; willing to make tough calls; consistently delivers results that meet or exceed expectations; demonstrates a track record of people development; champions diversity; net exporter of successful talent
- Intellectual Curiosity: sees the possibilities; willing to experiment; cultivates new ideas; comfortable with ambiguity and uncertainty
- Sense of Urgency: proactively senses and responds to problems and opportunities; works to reduce "cycle" time; takes action when needed

Other Competencies and skills

Proactive

Influence

Primary Location: México D.F.

Organization: Medical

Ubicación principal: America Latina-México-Distrito Federal-Ciudad de México

Organización: Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)

Área: Coordinador de aprobaciones