Head of Regulatory Affairs (m/f/d)

Troubleshooters from Bielefeld that inspire worldwide! Our strong brands: ALCINA, Alpecin, Bioniq®, KAREX, Linola, Plantur and Vagisan. Since 1905 we have grown as a family business in the cosmetics and pharmaceutical industry and are proud of our “Wolffsrudel” with more than 900 employees. We have 14 international offices and are active in over 60 markets. With our products we want to grow globally. Are you there?

We are looking for the next possible appointment to strengthen our team as Senior Account Manager (m/w/d)

Priority Development and implementation of regulatory strategies and processes for the new registration, registration and renewal of medicines and selected medical devices Monitoring and coordination of national and international authorisation procedures (e.g. EU, third countries) Management, Priority and Regulatory Assessment of Change Indicators (Variations, Renewals etc.) Technical communication with national and international regulatory authorities and with designated bodies Ensuring and further development of pharmacovigilance systems in close cooperation with the step plan officer / the QPPV Focus on cosmetics Responsibility for all regulatory issues relating to cosmetic products (including safety assessments, notifications, product information dossiers) Development of strategies for regulatory safeguarding claims and advertising statements for brands such as Alpecin and Plantur Support for marketing in the market launch of new cosmetic and OTC products in accordance with the relevant cosmetic and advertising regulations Observing and evaluating regulatory developments in cosmetics Leadership Professional and disciplinary leadership as well as further development of Regulatory Affairs (Pharma & Cosmetics) and pharmacovigilance teams Cross-sector cooperation (including R&E, QM, Marketing, Sales, Foreign Companies) to ensure regulatory compliance across the entire product lifecycle Strategic consulting of management and top management in regulatory issues incl. Testing and approval of central product information for domestic and foreign countries Controlling the digital administration and further development of regulatory and vigilance data as well as evaluating legislative trends and representing the company in relevant specialist bodies and associations

PhD in Pharmacy, Chemistry, Medicine or a comparable scientific field Multiannual professional experience in Regulatory Affairs Pharma & Cosmetics Consumer health products Leadership experience at group or department level, with responsibility for several teams Very good knowledge of the relevant regulations (e.g. AMG, EU-Pharmarecht, MDR / IVDR, EU-Kosmetik-VO, advertising and claim regulations) Sovereign communication with authorities and external partners and experience in international licensing procedures Very good English knowledge of word and writing; other foreign languages are advantageous Designed affinity for digital and AI-based solutions in Regulatory Affairs Strategic and analytical thinking, high decision-making and implementation skills and a cooperative, motivating leadership personality

Flexibility: Trust work time, mobile work (up to 25% per month) & over 30 days free Wolfferia: Daily fresh and balanced cuisine in our factory restaurant Sports & events: Cycling trips, cooking events, Christmas market & Co. Compatibility: Consultancy & Co. from Viva Family Service, chance to place in the KiTa „Werksgarten“ right around the corner Continuing & Learning: Language Courses, Seminars, E-Learnings, Knowledge Sessions & Co. Mobility: JobRad, JobTicket, E-Ladepillars & free parking Discounts: Discounts on our products & Corporate Benefits