Experience

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  Fresenius medical care

  Sept 2001 - Sept 2004

  Validations analyst

  Occupied pivotal roles in production and validation, garnering invaluable expertise in the inception and optimization of pharmaceutical manufacturing plants, alongside comprehensive insights into processes vital for pharmaceutical production and quality assurance.

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  Superintendencia de industria y comercio. colombian patent office

  Sept 2004 - Dec 2007

  Patent examiner biotech

  Assessment of State-of-the-Art Innovations in the Biotechnology Field, including Biotechnological Drugs, Agricultural Biofuels, and Bioremediation.Conducting thorough assessments of proposed IP-Biotech regulations or guidelines to evaluate their potential impact, efficacy, and viability for the agency.

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  Olarte raisbeck

  Jan 2008 - Mar 2011

  Quimica farmacéutica asociada

  Patent Prosecution for Pharma and Biotech Innovations in Colombia and Andean Region Patent Drafting for Colombian innovators

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  Innopreneurs sas

  Nov 2012 - Aug 2014

  Scientific project leader / consultora en materia de innovación,

  Technology Management and Intellectual Property;Coordination of innovation promotion and intellectual property projects with a market-oriented approach to Universities, Research Centers, entrepreneurship projects, and companies

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  Olartemoure

  Aug 2014 - now

  Regulatory affairs head

  • Orchestrated intricate regulatory strategies to facilitate Marketing Authorization (MA) approvals.• Provided strategic counsel on regulatory data protecion for New Chemical Entities (NCE).• Offered advisory services on navigating the dynamic Health Care landscape in Colombia, encompassing Medicines Price Regulation Regime and Commercial-Regulatory prerequisites for market entry.• Delivered comprehensive training sessions to scientists and entrepreneurs focusing on regulation and regulatory due diligence.• Formulated comprehensive reconsideration/appeal strategies for INVIMA and ICA, integrating technical, regulatory, and legal expertise.• Assisted innovators and entrepreneurs in the medical device sector in devising tailored regulatory pathways.• Collaborated with the Ethics and Compliance Departments to deliver insightful guidance on Medicines Promotion Standards, fostering constructive engagements with Healthcare Professionals (HCPs), Government Officials, and Patient organizations.• Conducted thorough reviews of global license agreements, addressing regulatory, pharmacovigilance, and Quality Assurance (QA) aspects for diverse Pharmaceutical Companies.• Evaluated advertising materials for compliance across various product categories including medicines, medical devices, supplements, and energy drinks.• Compiled Biotech Dossiers adhering to regulatory requirements.• Facilitated the acquisition, renewal, and maintenance of marketing authorizations from INVIMA, spanning a wide range of regulated products.• Obtained marketing authorizations for products surveilled by the ICA, such as licenses for the sale of animal feed, veterinary drugs, and mineralized salts.• Managed company and commercial establishment registrations before ICA and INVIMA. Show less