Job Description
Responsibilities
may include interviewing, hiring, and training employees; planning, assigning, and overseeing regulatory submissions.
About you:
Candidates with at least five years of relevant experience within a pharmaceutical company, CRO, CMO or similar organisation, with generalist regulatory knowledge, should have the skills and experience required for the role. We are also looking for:
Bachelor's degree in scientific/health fieldExcellent IT skills across all MS packages including Excel, Word, PowerPoint, Project, Outlook, TeamsExperience in compliance and maintenance of product life cycle databases and RIMs systemsStrong knowledge of EU regulatory framework and guidelines, and awareness of emerging markets submission rolloutsGlobal regulatory strategy and deployment decisions, defining strategic prioritiesExpertise in regulatory submission structure and content (e.g. MAA, NDA)Expertise in writing scientific and technical documents, and strong attention to detail in composing and proofing materialsMust be able to independently present complex global regulatory strategies internally and to Atnahs' partnersMust be able to communicate comfortably and effectively with regulatory authoritiesAbility to work independently, resolve problems, take initiative and scheduling and completing tasks to deadlinesAbility to work successfully across cross-functional teams and environmentsEnjoyment of working in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demandsAbility to build strong professional relationshipsExcellent professional English communication skills, both written and verbalWhat we offer:
We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.
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