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Andean Latam Cluster Lead
hace 2 meses
Pfizer is seeking a highly experienced Regulatory Affairs Director to lead our Andean Latam Cluster team. As a key member of our Regulatory Sciences organization, you will be responsible for providing strategic direction and oversight to ensure compliance with regulatory requirements and support the delivery of business objectives.
Key Responsibilities- Regulatory Strategy and Planning
- Develop and implement regulatory strategies to support the registration of new products and line extensions, post-approval variations, and lifecycle management.
- Ensure alignment with global and regional development and regulatory strategies to meet business objectives.
- Team Leadership and Management
- Lead and manage the Andean Latam Cluster team to achieve company objectives and culture.
- Develop and enhance the capabilities and capacities of the team through training and development needs.
- Regulatory Compliance and Quality
- Ensure all regulatory activities in the cluster are managed in compliance with Pfizer standards and international/local regulations.
- Implement and maintain quality systems, processes, and audit and inspection procedures.
- Stakeholder Management and Communication
- Develop and maintain effective relationships with local Regulatory Authorities and industry stakeholders.
- Communicate key issues and regulatory strategies to stakeholders.
- Education and Experience
- Scientific degree (life sciences or chemistry) or pharmacist degree.
- Minimum 10 years of experience in regulatory affairs, preferably in human medicines.
- Skills and Qualifications
- Strong leadership and management skills, including talent development, team working, problem-solving, communication, and interpersonal skills.
- Deep knowledge of national and regional regulatory legislation and guidelines.
- Ability to influence at all levels in the organization and build networks internal and externally.
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 expression, national origin, or disability.