Virginie Colas

Senior Regulatory Affairs Officer @Ethypharm

London, GB

Co-ordinate and / or prepare, review, submit and subsequently manage applications to designated Regulatory Authorities (EU and UK) in a timely manner for a range of products, through internal and Third Party workstreams, for the treatment of pain, addiction and critical care. · Regulatory advices/strategy for preparation, submission and approval of the submissions (e.g. variations, renewals, repeat use, international recognition procedure) · Monitor product safety information, prepare and maintain product labelling with national country requirements · Review and approve artworks for use in submissions and in production · Liaise with manufacturing, commercial, medical affairs and pharmaceutical development as well as external regulatory contacts (including third parties and regulatory agencies) · Monitor and advise on the impact of the Sunset Clause · Actively participate as primary regulatory resource in cross-functional project teams · Review regulatory submissions in eCTD format and submission via CESP or MHRA portal · Flexible and strive for continuous improvement · Collaborative and able to work in a global environment with multiple and diverse cross-functional teams · Time-Management skills · Able to work independently and proactively · Able to identify risk, with mitigations and resolutions to be presented to cross-functional teams · Anticipate and resolve complex regulatory issues · Able to construct, support and manage high visibility project plans (e.g. launches, international recognition procedure) · Able to prioritise workload and meet established goals and timelines · Coordinate and procure required documentation for regulatory submissions · Able to identify risk/ root cause and provide options for resolution with minimal impact on registration timelines · Analytical skills required to interpret regulatory data · Identify areas for improvement to systems, project plans and processes

Cité Scolaire Internationale, Lyon (69)

Scientific, German European Bachelor, Honors

Université Claude Bernard Lyon 1

Doctor of Pharmacy (Pharm.D.)

IPIL (Institut de Pharmacie industrielle de Lyon) in partnership with EM Lyon Business School

MSc (Master 2) for Health and Medicine Engineering-Technical Regulatory Affairs Option