Regulatory Affairs Specialist

hace 1 semana


Ciudad de México, Ciudad de México Pharmaceutical Research Associates, Inc A tiempo completo
Job Overview

We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Pharmaceutical Research Associates, Inc. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with Cofepris regulations for drug promotion/advertising and labeling.

The successful candidate will have excellent understanding of Cofepris regulations and experience interacting with the agency. Proficiency in Veeva Vault PromoMats or similar document management systems is an added advantage.

About the Role
  • Demonstrated expertise in regulatory requirements for labeling and advertising materials.
  • Experience in reading, interpreting, and evaluating regulatory guidance documents and initiating changes in systems to ensure regulatory compliance.
  • Knowledge of Common Technical Document and global guidelines on content and format of labeling preferred.
  • Experience with creating and reviewing labeling and advertising materials required.
Responsibilities
  • Manage multiple tasks and multifunctional resources concurrently, responding to rapidly changing priorities and aggressive deadlines.
  • Communicate effectively with all levels of personnel, both locally and globally.
  • Work independently with flexibility, connecting and collaborating with clients and team members remotely.
  • Provide strategic direction and innovative regulatory guidance, analyzing and interpreting efficacy and safety data.


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