Emmanuel Lechat

Freelance consultant on contract assignments to big pharma (SANOFI) or small start -up (ip Brokers, D&A Pharma ) • Provided input on Regulatory strategy, worked with KOLs on clinical/safety/pharmacovigilance responses (EU DCP) • Prepared Risk Management Plan (RMP) and labelling (SmPC, PIL). CMC compliance (SOPs, QA system), Business Dev • Analysed business processes to be harmonized (across Sanofi, Pasteur, Genzyme) with clinical, regulatory and IT leaders

Start -up (40 p). EU-US development for 3 - controled, prone to abuse - substances(approved in other fields) in CNS areas . • Devised development, clinical programs & filing plans (studies, risks, costs, timings) with management and project teams • Prepared briefing packs (CMC, clinical), CTAs & Responses. Attended Agency meetings (EMA, FDA, ANSM, LatAm). • Analyzed legislations/ new constraints. Pharmacovigilance, Risk Management (RMP). Supported Business Development

• provided advice on development and filing, most notably for a cancer vaccine, chronic hepatitis C, contraception. •prepared effective documents for filing and interfaced with authorities and clients to manage MRP/DCP dossiers. •presented ad-hoc analysis specific to products/ situations (ATMPs, compassionate use, accelerated assessment, compliance..) •adviced clients on the transition to eCTD (strategy, selection, implementation or outsourcing)

Barcelona (Spain), R&D headquarters. The largest Spanish pharmaceutical company • devised with teams and management EU-US strategy for pipeline compounds or combinations in asthma/ COPD. • monitored current and developing regulations, analyzing their impact on product or operations, with a major focus on EU /US • prepared European CTAs or line extensions coordinating their presentation and the annual budget • contributed to strategic decisions, and elaborated pediatric plans and submissions

Cambridge (UK), European headquarters. At a time of strong growth for PPD Europe (present in 33 countries with over 10,500 professionals worldwide), I provided regulatory consultancy to international clients and • contributed to the development or post marketing strategy. • drafted or reviewed clinical and regulatory documents • coordinated international clinical trial applications and submissions. • started elaborating with US counterpart electronic submissions offers .

After having created the Regulatory Operations Unit (3 staff) in London, I led its development in France in with the integration systems and processes across R&D (10 sites, 5 countries, 300 users) & affiliates. • investigated gains or risks in the implementation of global solutions for new legislations & internationalisation. • elaborated strategic recommendations & project planning. • constantly mediated between management, informatics & providers. • led the e-CTD selection & implementation.

London (UK), R&D Headquarters. Coordinated between headquarters, R&D functions, informatics & providers the definition / implementation of new clinical or regulatory systems. • provided expertise on global submissions requirements (content/format). • business leader in document/publishing syst. implementation & upgrade. • formalised business needs, reviewed technical & functional specifications. • developed training or educational support across functional areas.

London (UK), R&D Headquarters.Elaborated, together with international teams, strategies & dossiers for product development / registration UK, Ireland, Scandinavia, Australia, NZ, USA. • elaborated,with US Director, Briefing Package, IND, NDA for FDA. • led the 1st preparation & simultaneous MAA submission across Europe. • planned and submitted global dossiers (6 MAAs obtained) & responses. • prepared and coordinated variations, PSURs, renewals. • justified company's position to authorities.

Brussels (Belgium), European Headquarters. Contributed to the compilation and review of adverse events as registered in the product labelling throughout Europe for a key medicine (fluoxetine, Prozac) in view of elaborating arguments supporting desired claims.

5/6 years post A-level degree