(Senior) Manager Regulatory Affairs (f/m/d) LATAM

  • Mexico City, MX


Be part of our growing company

Are you eager to work in a dynamic company where new challenges and opportunities are part of your every day life? Then make PharmaLex your career choice!
 
PharmaLex is the leading service provider for the worldwide pharmaceutical industry in Regulatory Affairs, Pharmacovigilance and Development consulting. We are specialized in effectively designing all aspects of drug and medicinal product registrations - ranging from early development and market entry to product maintenance activities.
The success of our company resides in the expert knowledge and  high motivation of our employees.
 
We are looking for motivated, committed candidates who will enjoy working independently within our successful team in a challenging environment. So, if your career is much more than just a job for you but rather your passion, then come and join our successful team.
 
In Mexico City we are looking for a:

(Senior) Manager Regulatory Affairs 

Your responsibilities

As a part of our "Regulatory Affairs" team, your duties will primarily include the support of Latin America projects. You will operate within local and multinational Regulatory Affairs teams, collaborating with colleagues and clients. This includes the following duties: 
  • Participation in regulatory processes to gain and maintain marketing authorizations in Latin America  for human and veterinary medicinal products (application, renewal, variations)
  • Knowledge and provision of local and Latin America regulatory requirements
  • Regulatory Intelligence: Follow-up on the news, updates on regulations
  • Preparation of documents within the framework of regulatory affairs projects and submission to Health Authorities.
  • Maintenance of regulatory databases
  • Communication with clients and Health Authorities
  • Presenting seminars and lectures PharmaLex - internally, for customers and for professional audience

We offer you

  • Exciting and varied challenges in a friendly team
  • Contact and interaction with nearly all branches of the company, as well as many opportunities for personal development and job training

Your Profile

  • High School Diploma or Degree
  • 5 - 8 years of professional experience
  • Content-related experience in Regulatory Affairs
  • Fluency in spoken and written English
  • Strong service orientation
  • Good communication skills
  • Flexibility and dedication
  • Ability to convey a positive message
  • Ability to prioritize parallel tasks
  • Attention to detail
  • Strong sense of responsibility and pronounced motivation
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