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1 VAGA DE Relações Públicas EM São Paulo / SP
Função/cargo da vaga:
Relações Públicas
Empresa:
Nome da empresa disponível para cadastrados.
Salário:
A combinar
Cidade/Estado:
São Paulo / SP
Tipo de Vaga:
Home Office
Regime de contrato:
Efetivo/CLT
Descrição da vaga:
Req id: leading societies to a low carbon future, alstom develops and markets mobility solutions that provide the sustainable foundations for the futu... Job descriptions carry out the routines related to the operationalization of the activities of personnel administration, payroll, electronic point, access co... The lgt impact fellowship connects talents, with the desire to apply their professional skills in a more meaningful way, with leading social/environmental or... Oia global since its founding in 1988, oia global has grown into a $1 billion world-Class logistics and packaging company that employs over 1,200 professiona... Regulatory affairs director - Brazil, argentina and colombiahow might you defy imagination?If you feel like youre part of something bigger, its because you are. At amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-Better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join regulatory representative (lrr), director brazil, argentina and colombiathe local regulatory representative (director) is assigned to one or more amgen products, and leads the planning and execution of the regulatory strategies for that product(s) in their country(ies). The product(s) assigned have high complexity programs/strategies and high impact to focus in on brazil in terms of managing the regulatory team and the submissions, while local regulatory representative heads dedicated to colombia and argentina are in place and need to be in aligning local regulatory requirements with amgens corporate local input to and complete regulatory and handle local regulatory submissions in compliance with corporate standards and local regulatory guidance on local mechanisms to optimize product development and regulatory approvalsensure local labels are developed and maintained in line with local legislation and amgen standards and and support local regulatory product complianceact as the point of contact with regulatory agencies for activitiesgives for the filing plan (ma and lifecycle maintenance), advising and discussing with the local cross-Functional minimal supervision, implements the filing plan (ma and lifecycle maintenance) for their country(ies), where regulatory submissions are made on time and meet amgens corporate and local regulatory reviews, and approves source text for country labeling, and leads the country artwork based on source with regional and global study operations (gso) teams to support local planning and execution for clinical studies in accordance with national legal and regulatory requirements (where appropriate).Reviews and approves the promotional and non-Promotional changes in the local trade associations /national legislation and forwards information to local/regional groups presenting the impact to the external regulatory environment to help inform/advise in the regulatory decision regulatory product compliance (e.G. Imr, pmcs, pediatric and other agency commitments).Leads the regulatory submission of urgent safety communications, dhpcs & dils as required by amgen sops or local regulatory requirements, as authority interactions acts as the point of contact with br regulatory agencies in fulfilling local to local agency interactions and their and collaboration works closely with cross-Functional colleagues in the country, affiliate or hub to align on strategy and deliver country/affiliate/hub regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely with international regulatory leads (irls) and global regulatory leads (grls) to support the regulatory development, registration, and lifecycle management of all amgen with peers to ensure consistency on as contact and create relationships with agency staff on specific product assignment (if applicable).Establishes regular contacts and interactions with distributors (if applicable).Provide sme support to process improvement projects/specific activities assists locally in healthcare compliance activities where in local regulatory process improvements, initiatives, and all aspects of external vendor/contractor relationships where research maintains an awareness of new and developing legislation, regulatory policy and technical regulatory guidance relating to amgen productsperforms regulatory research to obtain relevant histories, precedence, and other information relevant to regional product advancementmentoringmentors and/or advises other(s) local regulatory representatives at more junior and skillsknowledge of regulatory with policies, procedures, and understanding of regulatory activities and how they have an effect on other projects and/or knowledge of national legislation and regulations relating to medicinal of the registration procedures/challenges in the country(ies) for ctas, mas and all lifecycle management and experience in the local regulatory environment relevant for product area and development of drug to anticipate regulatory agency questions and potential strong partnership social skills - Both oral and negotiation and influencing to understand and communicate scientific/clinical to anticipate and prevent potential to resolve conflicts and develop a course of action leading to a beneficial awareness and sensitivity to achieve results across both regional, country and international qualificationsdoctorate degree and 4 years of directly related experienceormasters degree and 8 years of directly related experienceorbachelors degree and 10 years of directly related experiencepreferred qualificationsin-Depth regulatory experience in the applicable country(ies).In-Depth knowledge of country(ies) legislation and regulations relating to medicinal you can expect of usas we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and opportunities to learn and move up and across our global organizationdiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actgenerous total rewards plan comprising health, finance and wealth, work/life balance, and career benefits.
Cód. 10036294
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