South LatAm Cluster Lead / Diretor Assuntos Regulatórios Latam South Sr (Location: São Paulo)

Pfizer; São Paulo; Híbrido; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading global pharmaceutical company is seeking a Regulatory Affairs Lead in São Paulo, Brazil. This role involves managing regulatory strategies, ensuring compliance with local regulations, and developing team capabilities. The ideal candidate should have over 10 years of regulatory experience, strong leadership skills, and fluency in English and Spanish. This position may require on-site work 2-3 times a week.

Qualificações

• Extensive experience in regulatory affairs for over 10 years.
• Proven ability to manage complex regulatory issues.
• Demonstrable knowledge across the drug development lifecycle.

Responsabilidades

• Lead the regulatory strategies for product registration and lifecycle management.
• Develop partnerships within the country and above-country functions.
• Ensure compliance with regulatory standards and policies.

Conhecimentos

Leadership

Regulatory affairs knowledge

Fluent in English and Spanish

Team working

Problem solving

Formação académica

Scientific Degree in life sciences or chemistry

Higher degree (MSc, MBA or PhD)

Descrição da oferta de emprego

Leadership and Strategic Role

• Lead and manage the cluster (Brazil and Argentina Region)/ country team in the development of regulatory strategies for registration of new products and line extensions, and their lifecycle management. Ensure that the team provides input into global and regional development and regulatory strategies to provide optimal support for meeting regional and country business objectives.
• Responsible for the leadership, development, and performance management of the Cluster/ country team to achieve company objectives and culture. Develop and enhance the capabilities and capacities of the team through the identification and implementation of training and development needs.
• Ensures that all regulatory activities in the country are managed in compliance with Pfizer standards and international/local regulations.

Internal Partnerships

• Develop strong partnerships within the country (e.g., Country Manager, Medical, Marketing, Supply Chain, Quality), and above-country functions (e.g., GCMC, GRS Regulatory Hubs, Regulatory Operations) and above-country GRS Categories and Regional Teams to facilitate the development and implementation of regulatory strategies to expedite the registration of new products, line extensions and life-cycle optimization.
• Provide strategic contribution to the country (PCO) leadership team – anticipate what Regulatory needs to contribute to achieve business objectives, e.g., BU Strategic and Operating plans.
• Collaborate with the Country lead to align on regulatory positions on pan-portfolio or policy topics for communication to in-country internal and external stakeholders.

Operational Excellence

• Ensure internal regulatory processes and procedures are followed according to Pfizer policies and procedures and support compliant regulatory activities.
• Assure local licenses in country under responsibility are maintained (e.g., Marketing Authorizations) in compliance with local regulations and following corporate policies, regulatory processes, and SOPs (e.g. CMC change control, product labelling, single channel of communication, etc.)

Clinical Trials

• Oversight of local Regulatory Authority submissions and approvals for Pfizer sponsored Clinical Trials, those that apply and the maintenance of approved CTAs.
• Ensure Country Regulatory Strategy accountabilities are fulfilled, and reduction of cycle times are a main driver of the operations while maintaining quality and compliance.

Qualifications

• Scientific Degree – such as life sciences or chemistry. Pharmacist degree may be mandatory in some countries.
• A higher degree (MSc, MBA or PhD) may be an advantage but is not essential.
• General management experience and previous line management and leadership experience at senior management level is essential
• Extensive experience in regulatory affairs preferably for more than 10 years, in human medicines.
• Proven ability to manage complex regulatory issues.
• Demonstrable knowledge across the Drug, Discovery, Development, and commercialization lifecycle, with proven examples of contribution.
• Proven ability to consistently deliver with agility to time, cost, and quality standards.
• Demonstrable experience of effective delivery in a complex matrix environment.
• Fluent in English and Spanish.

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 challenges and opportunities of the pharmaceutical industry.
• Knowledge and understanding of quality systems, processes, audit, and inspections.
• Ability to influence at all levels in the organization and build networks internal and externally.

Organizational Relationships

• Reports to VP. Head of Regulatory Sciences, Emergin Markets
• Member of Brazil Leadership Team
• Member of Extended local Commercial Leadership team (as applicable)

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, developing a long-term and positive relationship characterized by Integrity, Quality, Compliance and Leadership.
• Represents the Company at the local Regulatory Authority(ies) and lead the conversation in support to the achievement of Country Regulatory priorities aligned to country/regional advocacy/strategic plan.
• Partner with Regulatory Policy to develop and reinforce Pfizer regulatory positions with external stakeholders and understanding of the external environment.
• Understand local regulations and developing trends in the local regulatory environment of the country under responsibility and provide assessment of the impact to key stakeholders.
• Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies, and decision making.
• Influence on new legislation initiatives that could positively impact the business.
• Active participation in the local Trade Association(s) and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business.

Other Job Details

• Work Location Assignment:On-site 2-3x/week or as needed by the business.
• Last date to apply for job: August 13

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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