Analista Assuntos Regulatórios Pl. job from Pfizer in São Paulo, SP, Brazil
Friday 6th, May 2022
São Paulo, SP
Full-Time
Pfizer is a reputed company based in Dublin, County Dublin. We are looking for talented professional from the field of Environment/ Health & Safety to join our team as Analista Assuntos Regulatórios Pl..
JOB RESPONSIBILITIES
- In partnership with the local PGS and LATAM Regional Regulatory Hub, evaluate data received from the Headquarter and other areas of the company for elaboration of technical reports.
- In partnership with the local PGS, 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 local PGS, 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.
- When required, participate in meetings with ANVISA or other Agencies, Trade Associations (INTERFARMA, SINDUSFARMA, and others).
- Elaborate processes related to exportation documents.
- Follow-up at ANVISAâs website on product registration, line extensions and post-approval changes status.
- Keep updated on the latest changes to the legislation.
- Keep updated all Pfizerâs systems, share points and control spreadsheets related to all registration activities.
- Keep updated information related to regulatory area on Pfizerâs Brazil intranet.
- Perform all trainings required for the position.
Qualifications
- Certifications
N/A
- Education
Pharmacist
- Experience
2 years as Regulatory Affairs Jr Analyst
SKILLS
- Technical
Knowledge in sanitary legislation related to products registration and related subjects.Technical-scientific knowledge of pharmaceutical products.Good knowledge in English language.
ORGANIZATIONAL RELATIONSHIPS
Local PGS
LATAM Regional Regulatory Hub
Trade Associations (INTERFARMA, SINDUSFARMA, and others)
Brazilian Health Autorities
Business partners and stakeholders (marketing, supply, medical team, commercial area, etc)
Last day to apply for job: May 18th, 2022
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Skills required
How To Apply
Please submit your application as instructed in the job advert or Apply from Company Website
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