Regulatory Affairs Manager
vor 1 Tag
OmniVision GmbH is a leading non-corporate ophthalmology company with a strong presence in Germany and a growing network of locations in Austria, Italy, Spain, and Switzerland.
Job SummaryWe are seeking a highly motivated and experienced Regulatory Affairs Manager to join our headquarters in Puchheim near Munich. As a key member of our Regulatory Affairs team, you will be responsible for planning, coordinating, and submitting marketing authorization dossiers for ophthalmological products.
Key Responsibilities- Marketing Authorization Dossiers: Plan, coordinate, and submit marketing authorization dossiers for ophthalmological products with chemically defined substances (new developments, in-licensed products, export products).
- Regulatory Strategy Development: Develop regulatory strategies to ensure compliance with EU regulations and guidelines.
- Regulatory Due Diligence: Review marketing authorization dossiers for in-licensing and planned marketing authorization transfers.
- Module Preparation: Prepare modules 1, 2, 4, and 5 with the partial involvement of external consultants.
- eCTD Sequences: Prepare eCTD sequences and submit them to competent authorities via CESP or national submission portals.
- Scientific Advice: Plan, prepare, and conduct scientific advice meetings.
- Regulatory Activities Coordination: Coordinate regulatory activities in OmniVision subsidiaries (Austria, Italy, Spain, and Switzerland).
- Technical Support: Provide technical support for development projects.
- Regulatory Requirements Monitoring: Monitor, interpret, and implement new regulatory requirements.
- Internal Database Maintenance: Maintain and update the company's internal authorization database.
- Department Leadership: Serve as deputy head of the Regulatory Affairs department.
- Education: University degree in natural sciences, preferably Pharmacy, Biology, or Chemistry.
- Experience: At least 5 years of professional and practical experience in regulatory affairs (medicinal products) within the EU.
- Skills: Sound knowledge of EU/ICH regulatory guidelines and regulations, open-minded personality, ability to lead a team, service-orientation, analytical thinking, proactive thinking, and strong communication skills.
- Language: Fluent in German and English with excellent oral and written communication skills.
- Software: Excellent knowledge of Microsoft Office suite.
- Regulatory Experience: Experience in creating eCTD dossiers and maintaining Regulatory Information Management Systems (RIMS).
- Permanent Position: A permanent, long-term position in a successful, owner-managed medium-sized company in the pharmaceutical industry.
- Attractive Remuneration: An attractive remuneration package.
- Training Opportunities: Training opportunities for professional growth and development.
- Benefits: 30 days annual leave, flexible working hours, modern IT infrastructure, modern offices with employee parking, subsidized company meals, financial support for a job bike, payment of Germany ticket, and employee discounts.
-
Regulatory Affairs Manager
Vor 4 Tagen
Munich, Bayern, Deutschland SciPro VollzeitJobbeschreibung:Als Regulatory Affairs Manager - CMC bei SciPro unterstützen Sie das Regulatory Affairs-Team eines unserer Schlüsselkunden. Wenn Sie motiviert und an spannenden Projekten und innovativen Produkten interessiert sind, dann sollten Sie sich nicht zögern, sich zu bewerben!Was werden Ihre Aufgaben als Regulatory Affairs Manager - CMC...
-
Regulatory Affairs Manager
Vor 4 Tagen
Munich, Bayern, Deutschland SciPro VollzeitJobbeschreibung:Als Regulatory Affairs Manager - CMC bei SciPro unterstützen Sie das Regulatory Affairs-Team eines unserer Schlüsselkunden. Wenn Sie motiviert und an spannenden Projekten und innovativen Produkten interessiert sind, dann sollten Sie sich nicht zögern, sich zu bewerben!Was werden Ihre Aufgaben als Regulatory Affairs Manager - CMC...
-
Regulatory Affairs Manager
Vor 7 Tagen
Munich, Bayern, Deutschland Daiichi Sankyo Europe GmbH VollzeitAbout the Role:Daiichi Sankyo Europe GmbH is seeking a highly qualified Regulatory Affairs Manager to join our team in Oncology. As a key member of our regulatory team, you will play a critical role in ensuring compliance with technical and regulatory standards for our RACMC filings.Key Responsibilities:Lead and coordinate regulatory projects and filings in...
-
Regulatory Affairs Manager
Vor 3 Tagen
Munich, Bayern, Deutschland Daiichi Sankyo Europe GmbH VollzeitAbout the Role:We are seeking a highly qualified Regulatory Affairs Manager to join our team at Daiichi Sankyo Europe GmbH. As a key member of our regulatory team, you will be responsible for leading and coordinating complex regulatory projects and filings in the field of RACMC.Key Responsibilities:Lead and coordinate regulatory projects and filings in the...
-
Regulatory Affairs Manager
Vor 3 Tagen
Munich, Bayern, Deutschland Daiichi Sankyo Europe GmbH VollzeitAbout the Role:We are seeking a highly qualified Regulatory Affairs Manager to join our team at Daiichi Sankyo Europe GmbH. As a key member of our regulatory team, you will be responsible for leading and coordinating complex regulatory projects and filings in the field of RACMC.Key Responsibilities:Lead and coordinate regulatory projects and filings in the...
-
Regulatory Affairs Manager München
vor 11 Stunden
Munich, Bayern, Deutschland Triga Consulting GmbH & Co KG Vollzeit{"h1": "Regulatory Affairs Manager in München", "p": "Wir suchen einen erfahrenen Regulatory Affairs Manager für unser mittelständisches Pharmaunternehmen in München. Als Teil unseres Teams werden Sie nationalen und europäischen Zulassungsverfahren betreuen, qualitätsrelevante CMC-Dokumente erstellen und mit Zulassungsbehörden, Kooperationspartnern...
-
Regulatory Affairs Manager München
vor 11 Stunden
Munich, Bayern, Deutschland Triga Consulting GmbH & Co KG Vollzeit{"h1": "Regulatory Affairs Manager in München", "p": "Wir suchen einen erfahrenen Regulatory Affairs Manager für unser mittelständisches Pharmaunternehmen in München. Als Teil unseres Teams werden Sie nationalen und europäischen Zulassungsverfahren betreuen, qualitätsrelevante CMC-Dokumente erstellen und mit Zulassungsbehörden, Kooperationspartnern...
-
Regulatory Affairs Manager
Vor 6 Tagen
Munich, Bayern, Deutschland AMW GmbH VollzeitWir bei der AMW GmbH sind seit über 15 Jahren als pharmazeutisches Unternehmen tätig. Unsere Kernkompetenz sind innovative Drug Delivery Systems, zum Beispiel in Form von biologisch abbaubaren Implantaten zur Behandlung von Krankheiten. Unsere Experten entwickeln und produzieren medizinische Lösungen für internationale Partner und Patienten weltweit. Wir...
-
Regulatory Affairs Manager
Vor 6 Tagen
Munich, Bayern, Deutschland AMW GmbH VollzeitWir bei der AMW GmbH sind seit über 15 Jahren als pharmazeutisches Unternehmen tätig. Unsere Kernkompetenz sind innovative Drug Delivery Systems, zum Beispiel in Form von biologisch abbaubaren Implantaten zur Behandlung von Krankheiten. Unsere Experten entwickeln und produzieren medizinische Lösungen für internationale Partner und Patienten weltweit. Wir...
-
Regulatory Affairs Manager
Vor 5 Tagen
Munich, Bayern, Deutschland Daiichi Sankyo Europe GmbH VollzeitAbout Daiichi Sankyo Europe GmbHWe are a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer.The RoleWe are seeking...
-
Regulatory Affairs Manager
Vor 4 Tagen
Munich, Bayern, Deutschland Daiichi Sankyo Europe GmbH VollzeitAbout Daiichi Sankyo Europe GmbHWe are a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with cancer.The RoleWe are seeking...
-
Regulatory Affairs Manager
Vor 5 Tagen
Munich, Bayern, Deutschland OmniVision GmbH VollzeitAbout OmniVision GmbHOmniVision GmbH is a leading non-corporate ophthalmology company with a strong presence in Germany and a growing network of locations in Austria, Italy, Spain, and Switzerland.Job SummaryWe are seeking a highly motivated and experienced Regulatory Affairs Manager to join our headquarters in Puchheim near Munich. As a key member of our...
-
Regulatory Affairs Manager
Vor 5 Tagen
Munich, Bayern, Deutschland OmniVision GmbH VollzeitAbout OmniVision GmbHOmniVision GmbH is a leading non-corporate ophthalmology company with a strong presence in Germany and a growing network of locations in Austria, Italy, Spain, and Switzerland.Job SummaryWe are seeking a highly motivated and experienced Regulatory Affairs Manager to join our headquarters in Puchheim near Munich. As a key member of our...
-
Regulatory Affairs Manager
Vor 2 Tagen
Munich, Bayern, Deutschland SciPro VollzeitJob Summary:We are seeking a highly skilled Regulatory Affairs Manager - CMC to join our team at SciPro. As a key member of our Regulatory Affairs department, you will be responsible for supporting our clients in the preparation and submission of regulatory documents for pharmaceutical products.Key Responsibilities:Creation, organization, and administration...
-
Regulatory Affairs Manager
Vor 2 Tagen
Munich, Bayern, Deutschland SciPro VollzeitJob Summary:We are seeking a highly skilled Regulatory Affairs Manager - CMC to join our team at SciPro. As a key member of our Regulatory Affairs department, you will be responsible for supporting our clients in the preparation and submission of regulatory documents for pharmaceutical products.Key Responsibilities:Creation, organization, and administration...
-
Regulatory Affairs Manager
vor 10 Stunden
Munich, Bayern, Deutschland Daiichi Sankyo Europe GmbH VollzeitAbout Daiichi Sankyo Europe GmbHDaiichi Sankyo Europe GmbH is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with...
-
Regulatory Affairs Manager
vor 10 Stunden
Munich, Bayern, Deutschland Daiichi Sankyo Europe GmbH VollzeitAbout Daiichi Sankyo Europe GmbHDaiichi Sankyo Europe GmbH is a leading pharmaceutical company dedicated to discovering, developing, and delivering innovative treatments that improve the quality of life for patients worldwide.Our MissionWe strive to become a global pharma innovator with a competitive advantage, creating novel therapies for people with...
-
Senior Regulatory Affairs Manager
Vor 2 Tagen
Munich, Bayern, Deutschland Innovaderm Research VollzeitAbout the RoleWe are seeking a highly experienced and skilled Senior Regulatory Affairs Manager to join our team at Innovaderm Research. As a key member of our Regulatory Affairs department, you will be responsible for leading and managing regulatory activities across various regions, ensuring compliance with applicable regulations and good clinical...
-
Senior Regulatory Affairs Manager
Vor 6 Tagen
Munich, Bayern, Deutschland Innovaderm Research VollzeitAbout the RoleWe are seeking a highly experienced and skilled Senior Regulatory Affairs Manager to join our team at Innovaderm Research. As a key member of our Regulatory Affairs department, you will be responsible for leading and managing regulatory activities across various regions, ensuring compliance with applicable regulations and good clinical...
-
Senior Regulatory Affairs Manager
Vor 7 Tagen
Munich, Bayern, Deutschland Innovaderm Research VollzeitAbout the RoleWe are seeking a highly experienced and skilled Senior Regulatory Affairs Manager to join our team at Innovaderm Research. As a key member of our Regulatory Affairs department, you will be responsible for leading and managing regulatory activities across various regions, ensuring compliance with applicable regulations and good clinical...
