Highly experienced Regulatory Affairs & Clinical Development expert with over 14 years experience supporting multinational pharmaceutical, biotech and emerging biopharma companies as well as CRO and consulting companies. Successfully lead business critical and complex programs in Global Regulatory Affairs, Clinical Development / Trials, Divestments & Acquisitions and Asset wind-down. Represent the organisations with international Health Authorities, contractors, corporate partners and clients. My fundamental skills lie in the areas of: ✰ Regulatory Affairs specialist ✰ Pharmaceutical Project Management ✰ Cross-functional Teams ✰ Merger, ✰ Acquisition ✰ Divestment ✰ Stakeholder Liaisons ✰ Pharmaceutical Products ✰ Marketing Authorization Transfer ✰ Clinical Trials ✰ Clinical Development ✰ Regulatory Subject Matters Expert ✰ Biologic, chemical & generic molecules ✰ Cell and gene therapies ✰ Strategy ✰ Operations ✰ Biotech, Emerging Biopharma ✰ Multinational pharmaceutical companies ✰ Translations ✰ EU-CTR ✰ Project Management ✰ Regulatory Affairs lead
Autônomo
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AutônomoPortugal
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Regulatory Affairs & Clinical DevelopmentAutônomo Jan 2022 - PresentRemote
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Head Of Strategy & Operations, Iqvia Biotech, Asia Pacific-JapanIqvia Asia Pacific May 2021 - Nov 2021Singapore- Lead strategy and implementation of IQVIA Biotech clinical trial operations model Japan-Asia Pacific - Leading initiatives that enable IQVIA to deliver better for Biotech and Emerging Biopharma companies -
Engagement Manager, Biopharma Integrated Development Solutions–ApacIqvia Asia Pacific Jul 2019 - Apr 2021Singapore- Regulatory affairs expert for clinical development / trial programs - “Solutions architect” proposing tailored pathways to clients - Lead technical and R&D pharma consulting services for Biotech, Emerging Biopharma, and multinational companies- Oversee clinical development and regulatory projects such as China and USA pre-IND meetings and IND- Apply solutions in the Asia-Pacific region that includes China, Japan, USA and the EU
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Senior Consultant, Biopharma Integrated Development Solutions–ApacIqvia Asia Pacific Jul 2018 - Jun 2019Singapore- Regulatory affairs & clinical development expert - Oversight of Emerging Biopharma, Biotech, and Multinacional clinical development and regulatory projects- Support of clinical trial strategy and clinical development plans for selected molecules and coordinated Subject Matter Experts- Establish processes and communication flows with internal SME teams globally and within the departmentReceived “Make a Difference Award”, in the second quarter of 2018 for supporting project sales and deliveries for two major clients
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Consultant, Strategic Clinical Development-ApacIqvia Asia Pacific Sep 2017 - Jun 2018Singapore- Prepare clinical development and regulatory project proposals for clients in Southeast Asia (SEA) looking to expand globally- Leading SME supporting regulatory strategy for various consulting projects and expertly marketed and delivered several projects
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Senior Regulatory Manager - GlobalAspen Pharma Group Dec 2015 - Dec 2016Durban, Kwazulu-Natal, South Africa- Head crucial strategic Regulatory Affairs multinational projects for >100 markets- Establish regulatory strategy for each market- Lead and coordinate regulatory strategy and execution of worldwide medicine acquisition projects from multinational pharma company representing >200 Marketing Authorization Transfers- Prepare and present international and in-country strategy to stakeholders and oversaw strategy implementation in each market- Establish policy and processes- Coordinate regulatory intelligence gathering and interpretation for marketing authorization processes and product package introduction for each market- Liaise with governing affiliates to check project timelines, resolve issues, and respond to Health Authorities- Act as the regulatory and cross-functional team representative to support the strategy for introduction of Aspen product packages in the market and formulated the comprehensive acquisition project monitoring process -
Regulatory Project Team LeaderAspen Pharma Group Mar 2014 - Nov 2015Dublin City, County Dublin, Ireland- Oversight of regulatory submissions team for project acquisitions with 4 multinational pharmaceutical companies in the EU, US, EEU, CIS, and Canada for biological and chemical molecules- Plan, present and execute international and in-country strategy for each market- Schedule activities and resources for the Regulatory Submissions Team- Gather and analyse regulatory intelligence for marketing authorization transfers in each market- Create internal processes for acquisitions - Act as the regulatory representative for Health Authority auditsReceived the worldwide “Leader of the Year Award” for leading Regulatory Affairs to acquire products in the EU, EEU, the US, and Canada from two multinational pharmaceutical companies
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Senior Regulatory Affairs OfficerAspen Pharma Group Feb 2013 - Feb 2014Dublin City, County Dublin, Ireland- Regulatory Affairs product owner for several medicines (submissions and CMC) - Prepare and update CMC dossier- Manage and supervise commitments to Health Authorities for EU portfolio
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Regulatory Affairs Officer - EuropePharsolution - Pharmaceutical Consulting Oct 2010 - Jan 2013São João Do Estoril, Lisbon, Portugal- Prepare and submit to the Health Authorities variations and renewals for Mutual Recognition (MRP), Decentralised (DCP), Centralised (CP), and national procedures for generic and original molecules in the EU market- Set procedures, check status and track process in all markets, including liaising with the Health Authorities of each member state
Frequently Asked Questions about Margarida Silva
What company does Margarida Silva work for?
Margarida Silva works for Autônomo
What is Margarida Silva's role at the current company?
Margarida Silva's current role is Global Regulatory Affairs & Clinical Development, Acquisitions & Divestments, Pharmaceutical & Healthcare.
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Margarida Silva
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Margarida Silva
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Margarida Silva
Porto
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