6 days old

Analista Assuntos Regulatorios Sr. (Prazo determinado 1 ano)

So Paulo
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**Why Patients Need You**

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 Associate, 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**

+ Inform the relevant internal stakeholders, according to global and local policies and procedures, regulatory authority's approval of changes to the components for the DDCTA, DDCM and Clinical Trial Packages to ensure their timely and accurate implementation.

+ Liaise with CTA Regional LATAM HUB, to receive the required documents for clinical trials' related submissions.

+ Review all documents and dossiers related to submissions of new clinical trials and its maintenance, ensuring that dossiers to be submitted fully meet the local regulatory requirements.

+ Perform regulatory applications related to clinical trials initial submissin and maintenance.

+ Review regulatory packages prepared by CROs and perform regulatory submissions of these packages.

+ In partnership with GS local, Submission Hub e LATAM Regional Regulatory Hub, when applicable, support on preparation/submission of answer to Regulatory Authority queries.

+ Follow up on Health Authority website about the status of the submissions performed.

+ Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

+ When necessary, participate in meetings with ANVISA and other Trade Associations (Interfarma, Sindusfarma, etc).

+ Provide support to the Regulatory Affairs Coordinators and Regulatory Affairs Manager.

+ Perform data entry and quality control tasks associated in all regulatory systems impacted.

+ Keep the Safety team informed of adverse events according to relevant Standard Operating Procedures (SOPs).

+ Provide professional comments, recommendations, and information on relevant regulations to local colleagues.



+ Bachelor's Degree

+ 3+ years of demonstrated experience in Regulatory Affairs related to clinical trials.

+ Acceptable experience in regulatory affairs or other areas within clinical research universe.

+ Knowledge of National and Clinical Trials legislation, and guidelines

+ 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


+ Master's degree

+ Relevant pharmaceutical experience

**Other Job Details:**

+ Last Date to Apply for Job: June 18th, 2021

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

Regulatory Affairs

Posted: 2021-06-11 Expires: 2021-07-12
Sponsored by:
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Analista Assuntos Regulatorios Sr. (Prazo determinado 1 ano)

So Paulo

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