Regulatory CMC Writing Manager
Vor 6 Tagen
Regulatory CMC Writing Manager (m/f/d) View job here Regulatory CMC Writing Manager (m/f/d) Full Time Alfred-Wegener-Straße 2, 60438 Frankfurt am Main, Deutschland With Professional Experience 8/21/25 YOUR CONTRIBUTION As a Team Lead Regulatory CMC Writing (m/f/d), you will be the central contact point for our manufacturing site for development and maintenance of regulatory documentation to support creation of actual regulatory dossiers. This will include the following activities: Preparation of CMC documentation in compliance with internal requirements and in collaboration with the manufacturing organization Supervise a Regulatory CMC Writing Manager including coaching, performance review, ensuring compliance, and monitoring performance and its improvement Review draft documentation with the CMC RA and the respective site Conduct initial impact assessments, ensures justified documentation of changes Provide documentation per LoQ scope and timeline, and coordinates related tasks with the manufacturing site Define and coordinate required information and documentation with the manufacturing site and contractors to meet agreed regulatory timelines Support GMP inspections as needed Keep current on global CMC regulations and best practices YOUR PROFILE Completed scientific Studies in Pharmacy, Biology, Chemistry or a related field of studies, a doctorate is an advantage 3-5 years of professional experience dealing with regulatory affairs aspects within the pharmaceutical industry, especially with technical writing of module 3 Strong communication and problem-solving skills and analytical thinking ability Team Player with performance orientation and persistence Solution-oriented with a focus on compliance and quality Business fluent in English, German is an advantage YOUR BENEFITS Individual career development in a purposeful job: you improve the quality of life of our patients Hybrid work model that allows a good work-life balance Attractive location with good transport links, modern workplaces and a company restaurant Global family business with flat hierarchies and an open, respectful corporate culture Attractive remuneration with extensive social benefits Variety of employer-subsidized benefits such as WellPass, Deutschland-Ticket, Corporate Benefits and JobBike ABOUT US Welcome to Merz Therapeutics, a leading pharmaceutical company that helps people with movement disorders, neurological diseases, liver diseases and other health conditions regain their quality of life. We are proud to be a family-owned and value-driven company that has been dedicated to serving the needs of our patients for 110 years and is now a global innovation leader with products in more than 90 countries. Our goal is to use our products to improve treatment outcomes for patients around the world, thereby reducing the burden of suffering for affected people and their surroundings. Our dedication and commitment to relentless research and development is to ensure that unmet patient needs are identified and appropriate treatments are provided. Therefore, become part of our international and motivated Merz Therapeutics family now and help us achieve our goal: "BETTER OUTCOMES FOR MORE PATIENTS" For more information, visit https://www.merztherapeutics.com/. David Brodkorb Apply online | Powered by softgarden
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Team Lead Regulatory CMC Writing
Vor 5 Tagen
Alfred-Wegener-Straße , Frankfurt am Main, Deutschland Merz Therapeutics Vollzeit 80.000 € - 120.000 € pro JahrYOUR CONTRIBUTIONAs a Team Lead Regulatory CMC Writing (m/f/d), you will be the central contact point for our manufacturing site for development and maintenance of regulatory documentation to support creation of actual regulatory dossiers. This will include the following activities:Preparation of CMC documentation in compliance with internal requirements...
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Regulatory Affairs Manager
Vor 6 Tagen
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...
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Frankfurt am Main, Hessen, Deutschland The businesses of Merck KGaA, Darmstadt, Germany Vollzeit 100.000 € - 150.000 € pro JahrYour role: As Senior Manager Regulatory CMC, you will lead and drive global regulatory CMC activities for New Chemical Entities (NCE) and/or chemically synthesized drug-linkers for Antibody Drug Conjugates (ADC) during all clinical phases (I, II, III) and first registration until launch, as well as for post-approval development projects. You will develop...
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Director CMC
Vor 7 Tagen
Frankfurt am Main, Hessen, Deutschland Discover International Vollzeit 80.000 € - 120.000 € pro JahrDirector, CMC (Chemistry, Manufacturing & Controls)3 days a week onsite (Non-negotiable) and open to relocators from within EU.Our client is seeking an experienced CMC leader to take ownership of end-to-end CMC strategy and execution across multiple development programs. This role sits at the centre of technical development, ensuring our assets advance...
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Director CMC
Vor 6 Tagen
Frankfurt, Deutschland Discover International VollzeitDirector, CMC (Chemistry, Manufacturing & Controls)3 days a week onsite (Non-negotiable) and open to relocators from within EU. Our client is seeking an experienced CMC leader to take ownership of end-to-end CMC strategy and execution across multiple development programs. This role sits at the centre of technical development, ensuring our assets advance...
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Director, Global Cmc Regulatory Affairs
Vor 6 Tagen
Frankfurt am Main, Deutschland Otsuka Pharma GmbH VollzeitAnticipate, develop and recommend strategies and contingency plans, provide guidance, determine regulatory and scientific/technical requirements for CMC and GMP related submissions and enquiries for drugs, devices and drug-device combinations from the health authorities - Problems and issues faced are difficult and may require understanding of broader set of...
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Director, Global Cmc Regulatory Affairs
Vor 6 Tagen
Frankfurt am Main, Deutschland Otsuka Pharma Vollzeit**Jobbeschreibung**: - Anticipate, develop and recommend strategies and contingency plans, provide guidance, determine regulatory and scientific/technical requirements for CMC and GMP related submissions and enquiries for drugs, devices and drug-device combinations from the health authorities - Problems and issues faced are difficult and may require...
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Frankfurt am Main, Hessen, Deutschland Merck KGaA Vollzeit 80.000 € - 120.000 € pro JahrWork Your Magic with usReady to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...
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Regulatory Specialist
vor 2 Wochen
Frankfurt, Deutschland PERMACON GmbH Frankfurt VollzeitYour opportunity at an international company in the pharmaceutical industry! Our client, a leading company in the pharmaceutical industry, is looking to strengthen its team in Frankfurt am Main and is seeking a full-time Regulatory Specialist (m/f/d) – Pharma / CMC to start as soon as possible. 2 days per week remote work possible 37.5-hour work week...
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Regulatory Specialist
vor 1 Woche
Frankfurt am Main, Deutschland PERMACON GmbH Frankfurt Vollzeit**Your opportunity at an international company in the pharmaceutical industry!**: Our client, a leading company in the pharmaceutical industry, is looking to strengthen its team in** Frankfurt am Main** and is seeking a full-time **Regulatory Specialist (M/F/d) - Pharma / CMC** to start **as soon as possible.** - 2 days per week remote work possible -...
