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Gerente de Regulatorio

Fecha: 09-nov-2017

Ubicación: Santiago, CL

Empresa: MSD

Requisition ID: REG003392


MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


 


 


Position Objectives

 

Support Country/Southern Cluster in Quality & Compliance activities, including SOP Management, Training and Labelling Updating process as main responsibilities. Accountable for Distributors oversight throughout the Southern Cluster

 

Main Responsibilities:

 

Preparing submission dossier for labeling of MSD products (including the creation of the local labeling) in alignment with the corporate directions.

•             Comply with the company compliance directions and other required by MSD. Adherence to corporate process designed for labeling and artwork updates, ensuring timely submissions according to all applicable Policies and Procedures.

•             Keeping updates of local and corporate tracking tools and repositories associated with labeling and artworks.

•             Assuring the implementation of the new labeling through artwork management.

•             To prepare metrics and reports about the local performance for labeling and compliance.

•             Development and management of SOPs and training processes for the main Regulatory Affairs processes.

•             Integration and optimization for the above mentioned tasks in the Southern Cluster Region, ensuring process improvement and Cluster dashboard oversight and Global/Regional Q&C Systems implementation.

 

Competencies

 

•             Effective communication skills. Accurately and effectively communicates and shares information to peers, supervisors, teams and other stakeholders.

•             Demonstrates strong cross-functional teamwork skills to ensure appropriate management of Q&C processes.

•             Ability to function as a consultant to internal clients within the Cluster, providing them with expert advice on Labeling Updating Process.

•             Ability to proactively develop regulatory strategies for Labeling updates, in accordance with other Regulatory Life Cycle activities for the products

•             Prioritization and multitasking skills and ability to operate under uncertainty.

•             Project management skills, to ensure Cluster Systems implementation and monitoring.

•             Create new and innovative ways of doing and perceiving things, demonstrates flexibility, open-mind, and adaptability to a rapidly changing environment.

•             Integrate effectively the expected and unexpected changes keeping in mind overall MSD interest
Qualifications

Qualifications & Experience

 

Education:

•             Science Degree (pharmacist, biochemist, biology, biotech, genetics)

•             Advanced English language skills.

Experience:

•             Consolidated experience in regulatory affairs area for at least 5 years in multinational companies.

•             Good knowledge of the key regulatory processes, guidelines and framework related.

 

 

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. MSD’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. MSD is an equal opportunity employer, proudly embracing diversity in all of its manifestations.
We will consider candidates with special needs for this position.



Job: Regulatory Affairs Generic
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
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Company Trade Name: MSD