9 days old

Analista de Assuntos Regulatorios Pleno

Pfizer
So Paulo
**JOB SUMMARY**



+ Accountable for the labeling and artwork submissions execution ensuring country acceptability in terms of content, and alignment to local regulations and requirements. This includes regulatory authority (RA) query management.

+ Apply knowledge and interpretation of regulatory requirements in the assigned countr y( ies ) related to labeling and artwork processes.

+ Ensure dossiers ( e xample : electronic, paper copy, and regulatory authority portal) are produced and dispatched to markets according to their defined filing plan, and are submission ready.

+ Ensures the processes transparency and excellence in execution of regulatory strategies.

+ Maintain systems and databases are timely updated per internal SOPs and policies.

+ Work in collaboration across the organization with stakeholders ( eg. Product Strategist, Commercial, Operations) to deliver efficiencies in regulatory submissions and processes.



**JOB** **RESPONSIBILITIES**



+ Apply labeling expertise for LatAm countries to assure compliance and consistency according to the regulatory requirements and corporate policies throughout labeling and artwork processes.

+ Develop detailed understanding of labeling and artwork regulatory guidelines and technical requirements for LatAm countries.

+ Responsible for the execution of labeling and artwork processes in cooperation with in-country Regulatory , M edical , Hub Labeling Manager (HLM) , Artwork and Labeling Implementation Management (ALIM) and Marketing teams and other teams as applicable .

+ Prepare and/or coordinate dossier preparation guaranteeing quality dossiers, fulfilling country regulations and Pfizer standards.

+ Guarantee timely regulatory authority submission of the dossiers according to labeling category and/or regulatory strategy .

+ Ensure submission and approval timelines, and country registration requirements/guidelines are accurately captured and current in Global Pfizer Systems.

+ Manage the process to answer regulatory authority queries in coordination with stakeholders ( eg. r apid response teams, labeling group s , medical, in-country regulatory strategist, ALIM and marketing ) to guarantee approval of updated labeling a n d/or artwork information reflecting global Pfizer position for products as best in class.

+ Coordinate with ALIM the development and approval of labeling and non-labeling artworks .

+ Maintain informed stakeholders about last labeling approved by regulatory authority, as applicable.

+ Provide strategic support to the in-country regulatory strategists to facilitate achievement of labeling objectives.

+ Active participation and/or timely support in meetings, quality investigations and audit interviews impacting labeling and/or artwork operation .



**QUALIFICATIONS / SKILLS**



**Qualifications**



+ Bachelor's degree or equivalent i.e. degree in Pharmacy .

+ Two years of experience as regulatory affairs junior analyst .

+ Knowledge of the current framework for labeling and artwork is an advantage.

+ English advanced level: reading , writing, speaking and listening skills that are easily manifested in known contexts regarding work. Fluency in Spanish may be an advantage.



**Key Competencies**



+ Successful experiences of teamwork, seeking and proposing alternative solutions, achieving goals in an inclusive manner

+ Project management skills

+ Quality Focus and detailed oriented

+ Customer orientation

+ Analysis and problem solving

+ Effective communication

+ Strategically minded

+ Outward looking

+ Country/regional knowledge

+ Negotiation skills

+ Network and alliance building/ peer relationships

+ Influencing

+ Change agile



**Prazo limite para se inscrever vaga: 14/04/2021.**



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



Regulatory Affairs



\#LI-PFE

Categories

Posted: 2021-04-02 Expires: 2021-05-02

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Analista de Assuntos Regulatorios Pleno

Pfizer
So Paulo

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