Analista de Assuntos Regulatórios Sênior (Prazo determinado 16 meses) – Pfizer

Titulo da vaga: Analista de Assuntos Regulatórios Sênior (Prazo determinado 16 meses)

Empresa: Pfizer

Descrição da vaga: Why Patients Need You

This is a temporary position for 16 months. We’re looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

What You Will Achieve

Reliable documentation services form an essential component of a well-run Regulatory Affairs department. You will be the one entrusted with managing an efficient documentation system, record retention, and information services in compliance with regulatory requirements. You will ensure that procedures are in place to maintain records and interpret all documentation standards, policies, and operating procedure requirements. You will identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. You will maintain knowledge of product information and continuous contacts with local, regional, and divisional customers.

As a Senior, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

It is your hard work and dedication that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Perform activities related to initial dossier submissions and registration maintenance of company´s products, legal documents and/or systems. Supported, only if necessary.
• When required, participate in meetings with Anvisa, other Agencies and Trade Associations.
• Keep in touch with CMC and stakeholders in order to receive and provide the required support.
• Keep updated on the latest changes to the legislation.
• In partnership with submission Hub and LATAM Regional Regulatory Hub, elaborate and review all the documents and reports required for the new registration process, line extensions, post-approval changes, license renewals and Product Changes History, according to the legislation in force.
• Ensure and prepare query responses of the ANVISA or other agencies, gathering all the necessary information and elaborating the process in partnership with Submission Hub and LATAM Regional Regulatory Hub, when applicable.
• Interact with LATAM Regional Regulatory Hub in order to ensure elaboration of packages inserts and artworks of new products, as well as update the current package inserts and artworks according to international documents received from the Headquarter and Global SOPs.
• Follow-up at ANVISA’s website on product registration, line extensions and post-approval changes status.
• Keep updated on the latest changes to the legislation.
• Keep updated all Pfizer’s systems, share points and control spreadsheets related to all registration activities.
• Keep updated information related to regulatory area on Pfizer’s Brazil intranet.

Qualifications

Must-Have

• Bachelor’s Degree
• 3+ years of demonstrated experience in Regulatory Affairs or related function within pharmaceutical sector
• Ability to interpret and relay technical information, work with accuracy and provide attention to detail
• Ability to work independently as well as part of a team
• Proficiency in English, verbal and written
• Proficiency with computer and software applications

Nice-to-Have

• Master’s degree
• Relevant pharmaceutical experience

Last date to apply for job: Aug 31st, 2023

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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. Regulatory Affairs

Salário:

Local: São Paulo – SP

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