Sofia Campos Silva, RAC

Experience

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  Sofarimex

  Apr 2013 - Jan 2014

  Quality Assurance Officer

  • Reviewing the batch manufacturing record for product release, including solid, liquid, cream and lyophilized pharmaceutical forms• Preparing PQRs for systematic evaluation of key quality indicators and parameters• Assessing the consistency of the final product’s quality, monitoring the manufacturing/packaging and analytical processes, reviewing IPC and stability results, identify and report trends• Managing the data log of occurrences – deviation reports, change controls, and CAPAs • Training in Technical Regulatory Affairs, ICH guidelines, ISO9001:2008, and development of methods and technological transfers Show less

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  Pharsolution - Pharmaceutical Consulting

  Feb 2014 - Dec 2014

  Regulatory Affairs Officer

  • Lead submission of >20 generic MAAs for large pharma clients, including authoring of M1, M2 and M3 sections, liaising with stakeholders to obtain supporting documentation, compilation of the dossier, submission and response to expert queries – NP and MRP/DCP• Providing strategic support and guidance serving as national regulations expert• Liaising with HAs and relevant stakeholders to support HA-company interactions and the successful registration and launch of products• Preparing SOPs and regulatory related policy documents• Reviewing project-specific regulatory documentation to ensure compliance with applicable regulations and guidelines• Accountable for various life cycle management activities, including variations, MA transfers, renewals, review of promotional materials. Show less

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  Novartis Pharma AG

  Jan 2015 - Aug 2015

  Drug Regulatory Affairs Postgraduate, Global Regulatory Affairs

  EU regulatory intelligence and policy activities including:• Active monitoring of regulatory environment, evaluate and report impacts/risks for the company• Support the commenting of draft scientific guidelines• Develop internal guidance for optimizing the success of submissions in Centralised Procedure• Prepare EU Regulatory Intelligence monthly Newsletter for HQ and worldwide affiliates distribution• Various bench-marking activities (i.e. rapporteur vs. assessment outcome)• Member of the project team for the e-Application Forms testing and implementation Show less

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  Parexel

  Sept 2015 - Oct 2018

  • Project Leader of global post-marketing/life-cycle maintenance for vaccines and small molecules including a large pharma global license transfer project• Leading cross functional teams (>8p) to ensure that client work was performed within specified timelines and to client quality expectations• Developing and implementing global regulatory strategy for submissions of variations, MATs and other integrated regulatory activities in EU and RoW regions • Writing clinical summaries and overview for the Marketing Authorization Application of a new biologic product (mAb) to the EMA, and responses to D120 LoQ• Preparing Briefing Books for Scientific Advice meetings in EU• Preparing a PIP application for an orphan drug (human recombinant protein) including reviewing/drafting scientific document sections, KEF and Application Form• IB drafting/reviewing for IND/NDA submission (small molecules, oncology) Show less

  • Consultant, Regulatory Affairs

    Nov 2017 - Oct 2018

  • Senior Associate, Regulatory Affairs

    Sept 2015 - Oct 2017
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  UCB

  Nov 2018 - Nov 2024

  Neurology (Rare Disease)• EU/UK Regulatory Lead an ODD product (monoclonal antibody) in Myasthenia Gravis: - Leading development and filing activities in EU and UK, including late stage development, MAAs and OD applications, Scientific Advice, and Life-cycle maintenance - Building a robust relationship with the regulator as primary point of contact - Leading Agency meetings, managing Agency interactions, preparing the SME teams, communicating outcomes/impact to senior management - Planning and leading the execution of the LCM strategy for EU in collaboration with the GRL, other regions and in line with the RSP - Providing regulatory strategic guidance for the preparation of key clinical documents such as clinical summaries/overview and CSRs - Overall accountable for all regulatory submission deliverables, and ensuring timely and quality submissions - Oversight of pediatric development activities and CTAs• Line manager responsibilities• Internal initiative on MAA learnings and company guidance review Show less Neurology (Rare Disease) (Dec 2020-Sep 2022):• EU Regulatory Lead for an ODD product (monoclonal antibody) in Myasthenia Gravis, responsible for late-stage development activities and leading the European MAA, including acting as main point of contact for EMA - Leading Scientific Advice meeting with EMA, and (Co-)Rapporteur Pre-submission meetings - EU regulatory representative in RIMs - Providing regulatory guidance and revision to M2 documents and CSRs for pivotal studies supporting the MAA - Preparation of M1 components, overall dossier preparation and planning/timelines management for the EU submission (with support from PM) - Providing global regulatory support to Ph3 CTA activities• Internal initiative QMS @ GRA, involved in the drafting and review of PIP guidance • Mentoring responsibilities to junior team members and trainees Immunology (Nov 2018-Nov 2020):• Providing strategic leadership to cross-functional teams to deliver various submissions for Cimzia (antibody Fab' fragment) in EU, including CSR submissions, RMP and key label updates• Supporting the review of a PIP scientific document and preparation of KEF for a product in late development• EU lead for an early asset, responsible for the development of a regulatory strategy plan, providing strategic input for the design of the overall clinical development program, and planning and managing CTA applications for the FIH study• Support the Head of EU Regulatory Affairs with regulatory strategy for a newly acquired asset, to determine the optimal path for registration Show less

  • Associate Director, EU Regulatory Science Lead

    Oct 2022 - Nov 2024

  • Senior Manager, EU Regulatory Scientist

    Nov 2018 - Oct 2022
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  Takeda

  Jan 2025 - now

  Director, EUCAN Regulatory Affairs Lead Neuroscience