Stellenbeschreibung the opportunity: reporting to the general manager of csl vifor brazil, as the brazil regulatory affairs head, senior manager you will represent vifor global regulatory in brazil by providing support to the global gra project team and local affiliate with the preparation of the regulatory submissions, and supporting global regulatory affairs in the development and monitoring of long- And short-Term product regulatory planning related to new registration and life cycle management in brazil. You will also develop and evaluate registrations strategies to ensure effective achievement of regulatory/business objectives, approvals, and optimal labels. You will monitor national registration requirements through reviews of websites, publications, seminars, and similar sources, and communicate requirements to gra and local staff, as well as proactively address industry trends and opportunities, and key regulatory trends related to registration requirements supporting new product approval. This is a hybrid role, which requires some onsite work . The role: support the compilation, submission and maintenance of nda, in alignment with ra international strategy. Review and approve product information, customer medicine information, labels and other documentation as required for local regulatory compliance. Act as primary vifor ra representative in front of the anvisa (qp or deputy qp in the future. Interact with local ra partners and / or local health authorities to drive regulatory activities approval. Develop advocacy, support authority management with stakeholder mapping and proactively build and strengthen external stakeholder contacts (external experts, industry organizations, etc.) in brazil. Contribute to development of vifor local regulatory procedures and policies, including adapting global templates to local affiliate needs. Maintain gra archiving and tracking systems with local documents to ensure easy and quick access to all documents and transparency on activity status. Maintain up-To-Date regulatory intelligence on the local legislation and regulatory requirements and communicate requirements to gra and local staff. Inform relevant management functions of industry trends and opportunities that impact vifor portfolio and business. Coordinate and support the transition of the mas transfer to a new partner. Coordinate and support post ma transfer activities: due diligences, gap analysis. Life cycle activities. Work and support the implementation of vifor brazil as import and distribution company of drug products and pharmaceutical ingredients in brazil. Your skills and experience: registered pharmacist is preferred. University degree, preferably in pharmaceutical or health related field. Minimum 10 years in equivalent position in multinational companies in regulatory affairs in in the pharmaceutical industry (prescription drugs). Professional in portuguese and english (oral and in writing) required, with spanish knowledge preferred. Proven, first-Hand experience of working in a fast-Paced team environment. Proven, first-Hand experience of nda submission in brazil. Experience in working in a matrix organization and multidisciplinary team within the pharmaceutical industry. Familiarity with the global regulatory environment and gcp regulations. Good computer skills, including proficiency with ms office (including word and powerpoint. Able to influence regulatory policy shaping in brazil in different spheres such as federal government, estate and municipalities. High familiarity with cemed processes and the ability to bridge price, registration, and patient needs. High credibility with brazilian authorities and pharma associations. Have submitted minimum 10 products in the brazilian market, with vast experience in launches. Very good understanding on manufacturing, qq and qa. Experience in pharmacovigilance regulations and clinical development preferred. Experience in quality assurance and the stablish of a company as importer and distributor at anvisa level preferred. Ability to multitask and manage multiple and changing priorities with the ability to prioritize and delegate. Strong interpersonal skills and excellent communication. Very good cross functional work capabilities. Detail oriented with strong organizational skills and the capability to deliver operational objectives. High ethical standards and integrity. Ability to maintain a high level of confidentiality. Ability to work in a highly matrixed organisation and to establish successful cross-Functional working relationships with people in a wide variety of disciplines and backgrounds and be interpersonally aware and culturally sensitive. Applies entrepreneurial thinking and spirit. Applies strategic thinking. About us our benefits we encourage you to make your well-Being a priority. Its important and so are you. Learn more about at csl. About csl behring csl behring is a global leader in developing and delivering high-Quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about csl behring. We want csl to reflect the world around us as a global organisation with employees in 35+ countries, csl embraces diversity, equity and inclusion. Learn more about diversity, equity & inclusion at csl. Do work that matters at csl behring!.
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