Sr. Associate Regulatory Affairs

hace 5 días

Buenos Aires, Argentina Amgen A tiempo completo

Career Category Regulatory **Job Description**: Sr. Associate Regulatory Affairs Ensure life-cycle management for local products and production facilities as local regulatory lead for selected products (biologics and synthetic). Support RA senior staff, interface with the product teams, international regulatory, local QA/QC and supply chain. Interphase when specific strategies or activities that impact a product are required. Revise and Approve Promotional Material Works within Amgen systems for document management and change control management Interfaces with R&D and Operations personnel to coordinate preparation of regulatory filings, identification of issues and factors that may impact a regulatory strategy or activity including:- Post-market supplements- Annual report of minor changes and annual product reviews- Product Renewals- CMC investigational product amendments RA CMC Senior Associate will be responsible for varying levels of product support, and may lead projects, based upon their experience level Skills / Competencies: - >2 years regulatory experience in RA in the Pharmaceutical/Biotechnology industry, preferably biologics. ANMAT regulation and processes deep knowledge CMC- specific regulatory knowledge & experience with good working knowledge of CTD structure, preferably in biologics is preferable Strong interpersonal skills High accountability to follow through projects Excellent communication (both written and verbal), presentation and facilitation skills in English Ability to develop solutions to technical and organizational issues in order to improve performance and productivity Able to work independently and proactively Strong computer skills, including word processing, database document repository and project management software Able to influence vertically and across functional boundaries Strong team player with a commitment to customer service Basic Qualifications: - Master’s degree- Bachelor’s degree and 2 years Regulatory experience- Associate’s degree and 4 years Regulatory experience Preferred Qualifications: - Regulatory experience.- Commercial product life-cycle management experienceAmgen does not discriminate in its employment opportunities on the basis of sex, race, color, age, national origin, political or religious ideas, gender, sexual orientation, gender identity, level and type of disability, ethnic origin, or any other category protected by law. .

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