Regulatory Affairs Manager | (C732)

Regulatory Affairs ManagerPharmaceutical CompanyLocation: Girona, 9 Dic.Descripción:We are looking for a Regulatory Affairs Manager to build up and lead the new Regulatory team in a well-known company in the Pharma Industry, reporting to the Regulatory Affairs Director. This person should be located in the HQ in Girona 4 days a week. This role is a great opportunity for an experienced regulatory professional with broad regulatory experience.This position requires demonstrable knowledge of operational experience in Global regulatory affairs within the service industry or pharmaceutical companies. Due to growth within our Human Global Regulatory affairs team, we are looking for a Regulatory Affairs Manager who will be responsible for regulatory activities at a country level for Pharmaceutical products.You will have the opportunity to focus and develop your skills within international registrations in an interesting and challenging environment while evolving your consulting skills within a small and friendly team.Essential Functions Of The Role:Project Management/Leading Registration projects (end-to-end), involving several regulatory or technical deliverables.Providing strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, using innovative solutions where appropriate.Leading and managing the CROs team.Managing meetings with Regulatory Agencies (AEMPS, EMA, FDA, and local agencies).In the future, providing mentorship to junior colleagues and advising others on many regulatory document types.Planning and delivering workshops.Requisitos:Do you meet the skills educational and experience requirements for this role?Extensive experience within regulatory affairs.Vaccines or Drugs registration experience would be advantageous.Advanced negotiating and influencing skills and the ability to identify and resolve issues, using a flexible adaptable approach.Remains motivated and enthusiastic in times of change and other pressure situations.Degree in life science-related discipline or professional equivalent.Confident command of the English language both verbally and written.
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