Regulatory Affairs Coordinator

hace 3 semanas

Bogotá, Colombia Pfizer A tiempo completo

Regulatory Affairs Coordinator

Location: Colombia - Bogota - Suba

Time Type: Full-time

Posted: 3 days ago

JOB RESPONSIBILITIES:

  • Participate in the planning of Regulatory strategies for product submissions and lifecycle, including APIs related to products under her/his responsibility.
  • Coordinate and execute activities related to:
    1. Dossier planning and submission (paper and/or electronic) for initial registration and maintenance of Drug products, including product renewals for the assigned portfolio(s).
    2. Clinical Trial Applications (if applicable) for country acceptability in terms of content, according to local regulations and requirements.
    These activities include HA query management.
  • Provide accurate and timely information about the products which are under his/her responsibility for the country or countries of responsibility.
  • Interact with key internal stakeholders, such as Regulatory Strategists, GRS Product Strategists, Submissions Management, GCMC, Quality, PGS, and third-party vendors (as applicable), to ensure the regulatory strategies are executed according to the plan for business continuity.
  • Support the Regulatory Sciences Sr. Managers and Managers (as applicable) in the definition and execution of the regulatory strategies of assigned portfolios.
  • Work in collaboration across the region to deliver efficiencies in regulatory submissions and processes.

QUALIFICATIONS:

  • 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.
  • Proven ability to manage complex regulatory issues.
  • Proficient in English.

SKILLS:

  • Knowledge of local sanitary legislations and regulatory environment, including Clinical Trials Applications requirements (as applicable).
  • Technical and scientific knowledge of human pharmaceutical products.
  • Communication and negotiation skills.
  • Problem Solving.
  • Goals oriented.
  • Understanding stakeholder needs / Customer-oriented.
  • Strong quality and compliance orientation.
  • Analytical Thinking.
  • Ability to work under pressure.
  • Adaptability.
  • Planning and Organization.
  • Team player.

Change agile.

Work Location Assignment: Hybrid

EEO (Equal Employment Opportunity) & Employment Eligibility:

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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