Head of Global Regulatory Affairs CMC (m/f/x) in Böblingen, Unterensingen

IntroductionFrom a local pharmacy to an international pharmaceutical company: that's us, Wörwag Pharma.Our mission: Together for a healty life. We help to prevent and treat diseases of our time. Every day, we are committed to giving everyone the chance to live a healthy life - and have been doing so for more than 50 years!Would you like to actively support us with this plan?Head of Global Regulatory Affairs CMC (m/f/x)The Head of Global Regulatory Affairs - CMC holds a key position within our global organization and is responsible for defining and implementing the company-wide CMC strategy in the areas of development, regulatory approval, and lifecycle management. The position combines strategic and organizational leadership responsibilities with hands‑on involvement in regulatory CMC matters—particularly those that are complex, high-priority, or business-critical—as appropriate. The position holder reports to senior management, leads a global team across various locations, and serves as the primary Regulatory CMC point of contact for Quality, Product Development, Supply Chain, Manufacturing, and Sales, as well as for the entire Global Regulatory Affairs division.TasksTechnical and disciplinary leadership of the global Regulatory Affairs CMC function, including the HQ team and resources at other locationsResponsibility for all global CMC activities, including both new submissions and lifecycle management of existing approvals, as well as strategy developmentOperational support for complex and business-critical CMC projects, including dossier preparation, reviews, and communication with regulatory authorities.Establishment and management of governance structures for regulatory risks, escalations, prioritization, and decision-makingEnsuring regulatory compliance of all CMC dossier content (particularly Modules 2.3 and 3) worldwideAssessing the regulatory implications of product, process, and manufacturing changes, and coordinating implementation strategies with relevant functionsLeading regulatory activities related to site relocations, technology transfers, network changes, and post-approval strategiesResponsibility for due diligence activities in the context of business development, in-licensing, and M&A with a focus on CMCLeading resource, budget, and capacity planning, including prioritization, forecasting, and efficiency improvementsDeveloping employees, ensuring readiness for audits and inspections, and advising executive management on regulatory CMC issuesProfileA college degree in pharmacy, chemistry, pharmaceutical sciences, life sciences, or a comparable fieldAt least 10 to 12 years of professional experience in regulatory affairs and/or product development with a strong focus on CMCSeveral years of leadership experience managing large, international teams, some of whom work remotelyIn-depth knowledge of international regulatory requirements and guidelines (e.g., ICH, GMP, WHO) with a focus on CMCDemonstrable practical experience in CMC dossier preparation, evaluation, and lifecycle managementAbility to combine strategic leadership responsibilities with hands‑on involvement in complex technical issuesStrong knowledge of process and project management, digitalization, automation, and AI applications in the regulatory environmentEntrepreneurial mindset and the ability to balance compliance, business requirements, and feasibilityStrong persuasive skills at the senior management and regulatory agency levels, as well as experience in cross‑functional change and improvement projectsExcellent English skills, intercultural competence, high integrity, and willingness to travel occasionallyPay & PerksCompetitive, performance-based compensationEmployer contribution to a direct insurance planFlexible compensation componentVouchers for special occasionsMobility allowanceSubsidized meals in our company canteenCorporate benefits and employee discountsWork FlexibilityFlexible trust-based working hoursRemote working (up to 60%)30 days of annual leaveWorkplace & EnvironmentOn-site parking garageEV charging stations for cars and bicyclesExcellent public transport connectionsErgonomic workstationsOn-site canteen (Vitalbar)Free water and coffeeShowers and changing roomsCulture & Work VibeInternational collaborationFreedom to develop and contribute your ideasHands‑on approach & ownershipStrong team spiritLearning cultureCommunity & WellbeingRegular team eventsHealth & Wellbeing DaysWork-Life & Wellbeing PlatformDiscounts on over-the-counter (OTC) pharmacy productsResponsibility for People & PlanetHigh-quality products (often as market leaders)Support for social projectsFurther informationWörwag Pharma GmbH & Co. KGFlugfeld-Allee 2471034 Böblingen #J-18808-Ljbffr