Senior Manager Regulatory Affairs
vor 1 Tag
Job Title: Senior Regulatory Manager (Pharmaceuticals – Dermatology)Job SummaryThe Senior Regulatory Manager is responsible for leading regulatory affairs activities for pharmaceutical products, with a particular focus on dermatology. This role ensures regulatory compliance across the full product lifecycle and provides strategic regulatory guidance to support product development, registration, and lifecycle management in line with EU and national regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory strategies for dermatology products across development, registration, and post-approval lifecycle stages.Prepare, review, and maintain regulatory submissions and dossiers (e.g. MAA, variations, renewals) in compliance with applicable regulations.Act as the primary point of contact with health authorities and regulatory agencies, supporting meetings, responses to questions, and ongoing communications.Monitor and assess regulatory changes and evaluate their impact on existing and pipeline dermatology products.Provide regulatory guidance to cross-functional teams including R&D, clinical, quality, pharmacovigilance, and commercial functions.Support product labelling, artwork, and promotional material review to ensure regulatory compliance.Contribute to risk management, post-marketing commitments, and regulatory compliance activities.Support audits, inspections, and internal reviews related to regulatory affairs.Maintain accurate regulatory documentation and tracking systems.Qualifications & ExperienceDegree in life sciences, pharmacy, or a related scientific discipline.Significant experience in regulatory affairs within the pharmaceutical industry.Proven experience with dermatology products (Rx and/or OTC).Strong knowledge of EU pharmaceutical regulations and regulatory procedures.Experience working with health authorities and regulatory agencies.Excellent written and verbal communication skills.Key CompetenciesStrategic and analytical thinkingStrong project management and organizational skillsAbility to work cross-functionally and influence stakeholdersHigh attention to detail and regulatory compliance mindset
-
Senior Manager Regulatory Affairs
vor 1 Tag
Frankfurt am Main, Deutschland Medella Life VollzeitJob Title: Senior Regulatory Manager (Pharmaceuticals – Dermatology) Job Summary The Senior Regulatory Manager is responsible for leading regulatory affairs activities for pharmaceutical products, with a particular focus on dermatology. This role ensures regulatory compliance across the full product lifecycle and provides strategic regulatory guidance to...
-
Regulatory Affairs Manager
vor 8 Stunden
Frankfurt am Main, Hessen, Deutschland IFRS Foundation VollzeitLocation: Frankfurt or London. The IFRS Foundation operates under a multi-location operating model; morning and evening calls will occur occasionally. Duration: month contract Reports to: Director of Regulatory Implementation Job purpose: The Regulatory Affairs Manager plays a key role in the design, development and delivery of an effective...
-
Leitung Regulatory Affairs
Vor 4 Tagen
Frankfurt am Main, Hessen, Deutschland Real VollzeitLeitung Regulatory Affairs (m/w/d)Aktuell suche ich für unseren Kunden, einen Medizintechnikhersteller im Norden Hessens, nach einer erfahrenen Führungspersönlichkeit im Bereich Regulatory Affairs (m/w/d) in unbefristeter Festanstellung.Ihre Aufgaben:Entwicklung und Umsetzung globaler ZulassungsstrategienSteuerung regulatorischer Prozesse über den...
-
Regulatory Affairs Manager
Vor 2 Tagen
Frankfurt am Main, Hessen, Deutschland Merz Therapeutics VollzeitYOUR CONTRIBUTIONAs aRegulatory Affairs Manager (m/f/d) CMC, you will apply your knowledge of global regulatory quality requirements to support the approval and maintenance of medicinal products. Theposition is limited to 3 yearsand includes the following activities:Create, review, and update high-quality CMC documentation to obtain and maintain product...
-
Regulatory Affairs Manager
vor 1 Tag
Frankfurt, Deutschland Merz Therapeutics VollzeitRegulatory Affairs Manager (m/f/d) CMC View job here Regulatory Affairs Manager (m/f/d) CMC Full Time Alfred-Wegener-Straße 2, 60438 Frankfurt am Main, Deutschland With Professional Experience 7/22/25 YOUR CONTRIBUTION As a Regulatory Affairs Manager (m/f/d) CMC, you will apply your knowledge of global regulatory quality requirements to support the approval...
-
Senior Manager, Contracts Management
vor 1 Tag
Frankfurt am Main, Deutschland Medella Life VollzeitJob Title: Senior Regulatory Manager (Pharmaceuticals – Dermatology) The Senior Regulatory Manager is responsible for leading regulatory affairs activities for pharmaceutical products, with a particular focus on dermatology. This role ensures regulatory compliance across the full product lifecycle and provides strategic regulatory guidance to support...
-
Emea Regulatory Affairs
Vor 2 Tagen
Frankfurt am Main, Deutschland JPMorganChase Vollzeit**JOB DESCRIPTION** The position will also be responsible for deepening relationships with EU based regulators including but not limited to the ECB, ESMA, EBA, and the European Systemic Risk Board. The position will be based in Frankfurt. The role would require regular travels, primarily to London and EU countries (approximately 25% of the time). As a...
-
Regulatory Affairs Specialist Eu
Vor 4 Tagen
Frankfurt am Main, Deutschland Clinglobal Group Vollzeit**Regulatory Affairs Specialist - European Union** Clinglobal is an Animal Health Contract Research Organisation and supports our global operations in various countries. We are currently looking for a** Regulatory Affairs Specialist** based in the EU to join our growing Regulatory Affairs team at Clinglobal. This position offers the opportunity to work...
-
Regulatory Relations Manager
vor 2 Wochen
Frankfurt am Main, Hessen, Deutschland UBS VollzeitGermanyBusiness development, Business management, administration and support, Compliance, LegalGroup FunctionsJob Reference #326941BRCityFrankfurt am MainJob TypeFull TimeYour roleTo strengthen the highly qualified Regulatory Relations EMEA team we are looking for a Regulatory Relations Manager. In this role, you will be working in a dynamic and agile team...
-
Emea Regulatory Affairs
Vor 4 Tagen
Frankfurt am Main, Deutschland JPMorganChase Vollzeit**JOB DESCRIPTION** The position will also be responsible for deepening relationships with EU based regulators including but not limited to the ECB, ESMA, EBA, and the European Systemic Risk Board. The position will be based in Frankfurt. The role would require regular travels, primarily to London and EU countries (approximately 25% of the time). As a...