Regulatory Affairs Coordinator Expert

hace 4 días

Bogotá, Bogotá D.E., Colombia Pfizer A tiempo completo

Pfizer seeks a skilled Regulatory Affairs Coordinator to join our team. This is a full-time opportunity based in Colombia - Bogota - Suba.

The estimated salary for this position is $60,000 - $80,000 per annum, depending on experience and qualifications.

About the Role

We are looking for a highly motivated and detail-oriented individual to coordinate and execute activities related to regulatory strategies, dossier planning and submission, clinical trial applications, and product lifecycle management.

  • The successful candidate will have a Pharmacist graduated or life science degree and at least 3 years of experience as a Regulatory Analyst (Human Medicinal Products).

The role involves working closely with internal stakeholders such as Regulatory Strategists, GRS Product Strategists, Submissions Management, GCMC, Quality, PGS, and third-party vendors to ensure the execution of regulatory strategies according to plan.

Responsibilities
  1. Participate in the planning of Regulatory strategies for product submissions and lifecycle, including APIs related to products under her/his responsibility.
  2. Coordinate and execute activities related to dossier planning and submission (paper and/or electronic) for initial registration and maintenance of Drug products, including product renewals for the assigned portfolio(s).
  3. Provide accurate and timely information about the products which are under his/her responsibility for the country or countries of responsibility.
  4. Interact with key internal stakeholders to ensure the regulatory strategies are executed according to the plan for business continuity.
  5. Support the Regulatory Sciences Sr. Managers and Managers (as applicable) in the definition and execution of the regulatory strategies of assigned portfolios.
  6. Work in collaboration across the region to deliver efficiencies in regulatory submissions and processes.
Requirements
  • Education: Pharmacist graduated or life science degree.
  • Local Regulatory experience: minimum 3 years as Regulatory Analyst (Human Medicinal Products).
  • Demonstrable local Regulatory experience, including knowledge of NCEs and Biological products submission processes, CTAs applications (as applicable), and product lifecycle management activities.
  • Proven ability to consistently deliver on time and quality standards.
  • Proficient in English.
About Pfizer

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

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