Regulatory Sciences Director

hace 7 días

Santiago, Metropolitana, Chile Pfizer A tiempo completo
Andean Latam Cluster Lead (Regulatory Sciences Director)

Santiago, CLP

Job Summary

We are seeking a highly experienced Regulatory Sciences Director to lead our Andean Latam Cluster team. As a key member of our regulatory affairs team, you will be responsible for providing strategic direction and guidance on regulatory activities for the cluster, ensuring compliance with Pfizer standards and international/local regulations.

Key Responsibilities

  • Lead and manage the cluster team in the development of regulatory strategies for registration of new products and line extensions, post-approval variations, and lifecycle management.
  • Ensure the team provides input into global and regional development and regulatory strategies to support business objectives.
  • Responsible for the leadership, development, and performance management of the cluster team to achieve company objectives and culture.
  • Ensure all regulatory activities in the cluster are managed in compliance with Pfizer standards and international/local regulations.
  • Effective communication to stakeholders of key issues that could impact regulatory strategies or the business.

Requirements

  • Scientific degree in life sciences or chemistry, with a higher degree (MSc, MBA, or PhD) an advantage.
  • Minimum 10 years of experience in regulatory affairs, preferably in human medicines.
  • Demonstrable knowledge across the drug development lifecycle, with proven examples of contribution.
  • Proven ability to manage complex regulatory issues and deliver to time, cost, and quality standards.
  • General management experience and previous line management and leadership experience at senior management level.
  • Regional regulatory experience, including knowledge of NCEs and biological products submission processes, CTAs applications, and product lifecycle management activities.

Skills

  • Strong leadership qualities and management skills, including talent development, team working, problem-solving, communication, and interpersonal skills.
  • In-depth knowledge of national/regional regulatory legislation and guidelines.
  • Understanding of business and financial environment, drug development process, local healthcare system, and the pharmaceutical industry.
  • Knowledge and understanding of quality systems, processes, audit, and inspections.

Organizational Relationships

Internal Partnerships

  • Develop strong partnerships within the cluster and above-country functions to facilitate the development and implementation of regulatory strategies.
  • Provide strategic contribution to the country markets that support leadership team objectives.
  • Collaborate with EMB GRS and Consumer Health Regulatory cluster/country leads to align on regulatory positions on pan-portfolio or policy topics.

External Relationships

  • Responsible for developing and enhancing relationships with key external entities (HA's/BoH, RKOL's, etc.).
  • Manage the HA/BoH interface throughout the product development and product lifecycle.
  • Represents the Company at the local Regulatory Authority(ies).
  • Partner with Regulatory Policy to develop and reinforce Pfizer regulatory positions with external stakeholders.

Resources Managed

Head of Regulatory Sciences, Regulatory Sciences Manager, Coordinator, Analyst, Administrative Assistant

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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