2 days ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Blackfield AssociatesSenior International Consultant - Regulatory Affairs and Executive searchBlackfield Associates are further supporting a growing international pharmaceutical company who, due to continued growth and portfolio expansion are looking for Regulatory Affairs Director to oversee an Established Products portfolio, ensures compliance with regional and global regulatory requirements for existing and newly acquired products, develops and implements regulatory strategies, leads interactions with regulatory agencies and manages a regulatory team. Drives strategic planning based on European and UK regulatory guidelines for Infectious, Rare and Internal medicine/ disease.As Regulatory Affairs Director, you will be responsible for:Develop and implement regional and global regulatory strategies for established productsLead and manage interactions with regulatory authoritiesCollaborate with commercial, MSAT, CMC, Supply Chain, Medical Affairs and PharmacovigilanceAccountable for compliance by adhering to internal processes and external regional regulatory requirementsDefine the strategy to address regulatory changes in global markets and share knowledgeLead and coach Regulatory Professionals: make feedback to develop team members, define clear objectives for the team in alignment with company goals, make responsible decisions to drive performanceTo be considered for the role of Regulatory Affairs Director, you will have the following experience and qualifications:Must have significant experience of managing lifecycle regulatory activities for established products including new therapeutic indications and safety variations impacting SmPC and Package LeafletEducated to advanced degree level in a life science disciplineExpert knowledge of regulatory affairs in Infectious disease and Internal Medicine therapeutic areasSound knowledge of Quality and Clinical guidelines in EU and the UKPrior hands-on experience of leading technology and marketing authorisation transfer in EUProven hands-on experience with EU regulatory procedures, especially MRP/DCP/CP and NPPrevious demonstration of working effectively as part of CMC team with strong collaboration with Manufacturing, Science & Technology team (MSAT)Experienced in working in a matrix environmentWell versed in CMC and clinical variation classifications and submission requirementsAbility to think strategically within a complex business critical and high profile established productThis is a full time permanent position, working Hybrid working – 3 days a week from the office in Windsor.Seniority levelSeniority levelDirectorEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceIndustriesRetail Pharmacies, Medical Practices, and Pharmaceutical ManufacturingReferrals increase your chances of interviewing at Blackfield Associates by 2xSign in to set job alerts for “Director of Regulatory Affairs” roles.London, England, United Kingdom 2 months agoDirector of Compliance & Regulatory AffairsCity Of London, England, United Kingdom 2 days agoGreater London, England, United Kingdom 3 weeks agoGlobal Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager)London, England, United Kingdom 1 week agoGlobal Regulatory Affairs Director (Global Program Regulatory Director)London, England, United Kingdom 2 weeks agoU.K./European Regulatory Affairs DirectorLondon, England, United Kingdom 1 week agoHead of Group Regulatory Policy- Corporate AffairsLondon, England, United Kingdom 3 days agoSenior Director - Government & Regulatory AffairsLondon, England, United Kingdom 2 weeks agoDirector CMC regulatory Processes and systemsLondon, England, United Kingdom 3 weeks agoLondon, England, United Kingdom 6 days agoDirector Quality Assurance and Regulatory AffairsDirector Quality Assurance Regulatory AffairsCity Of London, England, United Kingdom 2 days agoHammersmith, England, United Kingdom 1 day agoHead of Product Compliance + Regulatory AffairsLondon, England, United Kingdom 3 days agoUxbridge, England, United Kingdom 2 hours agoSenior Director, Governance & Operations LeadLondon, England, United Kingdom 1 week agoAssociate Director, Public Affairs - Award Winning Communications AgencyLondon, England, United Kingdom 1 month agoSenior Public Affairs Manager (12 months FTC)London, England, United Kingdom 5 days agoAssociate Director, Public Affairs - Award Winning Communications AgencyLondon, England, United Kingdom 1 month agoLondon, England, United Kingdom 2 weeks agoSenior Public Affairs Manager (12 months FTC)London, England, United Kingdom 2 weeks agoBuckinghamshire, England, United Kingdom 4 weeks agoUxbridge, England, United Kingdom 2 weeks agoFarnborough, England, United Kingdom 2 weeks agoMaidenhead, England, United Kingdom 3 days agoLondon, England, United Kingdom 23 hours agoLondon, England, United Kingdom 2 weeks agoLondon, England, United Kingdom 2 days agoLondon, England, United Kingdom 1 month agoHigh Wycombe, England, United Kingdom 6 days agoWe’re unlocking community knowledge in a new way. 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