Regulatory Affairs Manager- In Vitro Diag CAC

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Guarantee the accomplishment of all sanitary regulation requirements within the countries of the region

assigned under her/his responsibility, including provide support on any regulatory affairs matters

required for commercial operation of local organizations.

To develop, establish, implement, report and follow up the strategy and local initiatives regarding

regulatory operations and policy, in alignment with global and affiliate’s strategy, in order to provide

Support To Other Areas/functions About These Topics.
The Opportunity:

• To Define and Execute, together or in consultation with the Chapter Director, a regulatory Policy
  
  

strategy for sanitary legislation and standardization, in alignment with the global policy strategy

and positions.

• Guarantee the establishment of an adequate regulatory environment with Health Authorities for
  
  

our products in order to facilitate business growth.

• To represent the company with local authorities and associations or industrial Chambers in forums
  
  

related to sanitary regulation.

• Monitor the legal and regulatory developments, changes or implementations in the countries of the
  
  

region and escalate the information to the Leadership Team whenever is needed.

• Accountable of the development and execution of a plan regarding all the regulatory operations
  
  

needed to maintain business sustainability, including, but not limited to: new products sanitary

registration processes, modifications, renewals and technical evaluations requirements for

sanitary registration of products in the countries needed.

• Constantly interact with global and regional colleagues in order to improve the activities related to
  
  

the department in line with the implementation of Roche’s operating principles.

• To guarantee the active support to local organizations and marketing, sales and logistic
  
  

departments by his/her team to achieve the goals defined by the affiliate.

• To define, implement and monitor a follow up system for all sanitary licenses of the region
• To perform other functions according to the requirements of the immediate superior
• To collaborate closely with the area Director in any projects or activities that the department
  
  

requires.

Who you are:

• University Degree in Health Care related careers and/or Legal
• Knowledge and working experience on regulatory operations and regulatory intelligence activities
• Experience preparing, performing, reporting and following on regulatory processes
• Experience as direct or indirect people leader
• Experience awithin the industry of IVD or healthcare in similar positions as Regulatory Affairs
• Spanish/ English advance level
  
  

Key Competences:

• Passion for leadership
• Computer skills intermediate to advance level
• Focused on the analysis and solution of problems
• Advance organization skills, proactive, dynamic and with initiative
• Excellent communication skills
• Focused oriented and ability to prioritize
• Adaptable to work on team or alone in an efficient manner
• Clear sense of accountability on the tasks and responsibilities assigned
  
  

The position could be based in Panamá, Guatemala or Costa Rica.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.