Vice President Regulatory Affairs
vor 23 Stunden
Role OverviewWe are representing our client in the search for a Vice President, Regulatory Affairs, based in Germany (remote). This role provides executive-level responsibility for leading the regulatory function and shaping regulatory strategy across Germany and Europe within a growing pharmaceutical organisation.You will define and execute regulatory strategies covering clinical development, marketing authorisations, and lifecycle management of pharmaceutical products. Acting as the primary interface with regulatory authorities. You will ensure regulatory considerations are embedded across R&D, Clinical Development, Quality, and Commercial functions to support efficient development timelines and successful product launches.Key ResponsibilitiesRegulatory Strategy & LeadershipDefine and implement regulatory strategies for clinical programmes and product registrations in Germany and the EUAdvise the Executive Board on regulatory risks, opportunities, and compliance considerationsAlign regulatory strategy with corporate objectives to maximise patient access and commercial outcomesRegulatory OperationsLead regulatory submissions and approvals, including CTA, MAA, variations, renewals, and post-approval commitmentsManage interactions with BfArM, PEI, EMA, and other relevant health authorities to facilitate approvals and resolve regulatory issuesEnsure compliance across the full product lifecycle, including post-marketing obligations and safety commitmentsTeam Leadership & DevelopmentBuild, mentor, and lead a high-performing Regulatory Affairs team across clinical, CMC, and lifecycle activitiesDrive cross-functional collaboration to ensure regulatory requirements inform early-stage development and commercialisation planningExternal RepresentationRepresent the company in discussions with regulatory authorities, industry associations, and professional forumsEstablish strategic relationships to strengthen the company’s regulatory credibility and visibility in Germany and EuropeCandidate ProfileAdvanced degree in Life Sciences, Pharmacy, Medicine, or a related discipline; PhD or MD strongly preferred15+ years’ experience in pharmaceutical Regulatory Affairs, including significant senior leadership responsibilityStrong experience with German regulatory authorities (BfArM, PEI) and European regulatory frameworks (EMA)Proven track record of leading successful regulatory submissions and approvals across multiple therapeutic areasSolid understanding of clinical development, CMC, and product lifecycle managementStrong leadership, strategic thinking, and stakeholder management skillsExperience leading remote and cross-border teamsLanguages: Fluent English (Required) & German (Preferred)
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Essen, Nordrhein-Westfalen, Deutschland E VollzeitE.ON SE | Permanent | Part or Full time E.ON is one of Europe's largest operators of energy networks and infrastructure and a provider of innovative energy solutions. Our employees are constantly working to digitise the energy world, achieve net zero and connect everyone to good energy. To achieve this, we are focusing our actions on sustainability,...
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Essen, Deutschland E VollzeitE.ON is one of Europe's largest operators of energy networks and infrastructure and a provider of innovative energy solutions. Our employees are constantly working to digitise the energy world, achieve net zero and connect everyone to good energy. To achieve this, we are focusing our actions on sustainability, digitalisation and growth. We strongly believe...
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Corporate Public Affairs Specialist
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Essen, Deutschland Brenntag Vollzeit**CORPORATE PUBLIC AFFAIRS SPECIALIST (M/W/D)**: Unser Team hat am Standort in **Essen **momentan eine freie Position als **Corporate Public Affairs Specialist (m/w/d)** zu besetzen. Wir bieten Ihnen eine sehr spannende und abwechslungsreiche Tätigkeit ganz nah an den Entscheidungsträgern unseres Unternehmens. Sie berichten im CEO-Ressort direkt an die...
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Essen, Nordrhein-Westfalen, Deutschland Ramboll VollzeitJob Description Locations: Munich, Bad Kreuznach, Frankfurt, Berlin, and Essen.Welcome to Ramboll, a global leader in chemical and pharmaceutical regulatory consultancy. We specialize in managing registration and approval procedures for chemicals, biocides, agrochemicals, pharmaceuticals, and medical devices. With over 160 experts from various countries, we...
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Essen, Deutschland E.ON Energie Deutschland GmbH VollzeitBei **E.ON** zählt Vielfalt. Wir heißen alle Menschen willkommen und sind überzeugt, dass Unterschiede uns stärker machen. Wir leben unsere inklusive und vielfältige Unternehmenskultur! Wir wollen, dass unsere Jobs zu jeder Lebenssituation passen. Deshalb bieten wir eine Beschäftigung wahlweise in Voll - oder Teilzeit und im Tandem an. Gemeinsam...
