Support the implementation and execution of regulatory and quality plans, and perform any regulatory activities for products marketed by werfen. key accountabilities - support raqa management with a business focus. - ensure compliance with raqa record management processes. - lead and manage non-conformities, follow-up plans for capas. - document tracking and control in sap. - regulatory submissions to invima and other regulatory entities. - preparation and updating of quality agreements. - management of regulatory and quality databases. - follow-up on regulatory processes with the factory. - follow-up and preparation of meeting and committee minutes. - provide technical and sanitary product documents. - issue letters to customers. - review registration requests received in detail and provide appropriate responses and support to stakeholders. managed budget (if applicable) & kpi - ensure timely submission of regulatory dossiers. - track regulatory plans and quality assurance planning (audit plan, training plan, document management plan, change management, and risk management). - generate improvement proposals, continuous development, and involvement in projects. internal networks/key relationships to be determined based on departmental needs, including interactions such as: - customers - external suppliers (logistics operator, certifying entities, invima, andi, agen) - marketing managers - department managers/directors - general manager - commercial team - specialists and technical support team - clinical specialists skills and abilities: ...
The position reports to the vp of commercial operations of latam. the general manager latam distribution is responsible for finding, creating, and consolidating business opportunities in latam countries in which werfen commercializes products through distributors. based upon werfen's value selling framework, the position holder should increase the distributors' commercial capabilities and develop a proposal to expand werfen's blueprint in all countries of responsibility. key accountabilities: - develop budget, forecast, and 3-year plan with leadership team and finance. - develop short-term and mid-term business strategies aligned with corporate strategy. - maximize local performance by translating the strategy into specific action plans that will drive results. allocates resources accordingly. - responsible for the whole p&l; of the affiliate. - is very commercial-oriented – enjoys building and maintaining strong partnership relationships with important customers, opinion leaders, and decision-makers. - supports the executive team of the affiliate when it comes to closing important deals or negotiating tough agreements. - dedicate quality time with customers including as much traveling as needed: visiting them, discussing with them, understanding their needs, and gathering a good sense of the fit between customers’ needs and werfen's portfolio of solutions. - is an expert on market trends, and well-versed in the economical-social-political environment of the country. - is one of the legal representatives of werfen in colombia as support lr colombia. - invests a...
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