Regulatory Science Analyst

Detalles de la oferta

JOB SUMMARY Support the Regulatory team in the activities associated with new product registration and post-approval changes during the product lifecycle for the assigned portfolio. Work in collaboration across the Cluster/Country (as applicable) to deliver efficiencies in regulatory submissions and processes. Interact with local Regulatory Teams, Regional Hub Teams, PGS, GCMC, GRO (e.g.: SM, PPLS, CDM, GRRS) and key local and regional stakeholders (as applicable) in order to fulfill the assigned responsibilities. Familiarize with the latest changes in BoH legislation. JOB RESPONSIBILITIES Possess a thorough understanding of the Cluster/Country (as applicable) market requirements, as well as the regulatory processes. Work closely with the local Regulatory team, LatAm Regional Hub, and other stakeholders as applicable (e.g. PGS, Submission management, GRO, GCMC) to support the execution of the Regulatory Strategies associated with initial submissions, line extensions, and post-approval changes. Provide the necessary information to ensure internal systems and databases are updated. Work with the local team regarding the evaluation of data received from Headquarters and other areas of the company for the elaboration of technical reports. Partner with Regional Hub and PGS as applicable to perform this evaluation. Participate in the discussion and preparation of HA query responses, working in partnership with the local Regulatory Team, Regional Hub, and above-country stakeholders. Routinely monitor Health Agency's website for information related to product registration, line extensions, and post-approval changes. Understand and keep current with reference to local regulations and trends. Collaborate in the process of timely communicating new regulations and trends as well as RRM maintenance. Keep updated all Pfizer's systems, SharePoints, and control spreadsheets related to all registration activities. Complete departmental training in a timely manner to address corporate and regulatory needs. As applicable, contribute to local regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation, and talent development and retention. Qualifications Experience: Regulatory Jr. Analyst, pharmaceuticals for humans - minimum 1 year. Education: Bachelor's degree or equivalent, i.e., degree in Chemistry, Pharmacy, or a related life science. Certifications: N/A SKILLS Change agile. Knowledge of local BoH requirements, as well as the requirements for the markets in the Cluster. Technical and scientific knowledge of pharmaceutical products. Proficiency in the English language is preferred. Team player. 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. #J-18808-Ljbffr


Salario Nominal: A convenir

Fuente: Whatjobs_Ppc

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