Regulatory Affairs Cmc Lead
vor 2 Monaten
Focus of the role:
Lead and manage CMC regulatory activities related to Biosimilars for development, initial MAA/BLA registration and post approval life cycle management (LCM) worldwide.
Define the RA-CMC strategy for the assigned programs and lead execution in close collaboration with internal and external stakeholders
Your assignments
- As Business partner to the Biosimilar CMC team and Product Teams, represent the regulatory team in CMC and cross-functional forums.
- For the assigned products/programs, define and execute an RA-CMC Strategy that best serves the biosimilars business needs and ensure compliance with regulatory systems.
- Change Controls evaluation.
- Planning and coordination of CMC related submissions with regulatory functions.
- Track approval and provide regulatory input for changes implementation strategy in close collaboration with Quality, Supply and CMC functions.
- Represent and defend the Company strategy in front of Health Authorities
- Respond to HAs questions in line with the Company CMC strategy. Elaborate responses in close collaboration with CMC teams and site representatives in a timely manner.
- Create comprehensive story lines for submissions.
- Participate to HAs meetings and present the RA-CMC submissions content to assessors, seeking endorsement of the Company strategy.
- Manage externalization of RA-CMC activities as required.
- Ensure regulatory CMC requirements are met along the assigned project development work.
- Keep up to date with the latest regulatory CMC requirements through regulatory surveillance. Coordinate timely implementation of any changes or new relevant laws or guidance; provide comments on new laws on behalf of FK-SBS through the appropriate procedure, as applicable.
- Serve as an interface between company functions as appropriate.
- Manage distribution of RA-CMC activities within sub-team, external and internal partners as required.
- Prepare briefing books and provide support at Regulatory agencies meetings on CMC aspects.
- Ensure that the input in quality development incorporates the outcome of consultations and negotiations with Regulatory Authorities.
- Carry out regulatory review of study / technology transfers protocols and reports used as CMC source documentation for the regulatory sections authoring. Liaise with authors and data generating functions as applicable.
- Ensure regulatory filing systems are maintained and up to date.
- Lead CMC Regulatory task forces on assigned projects.
**Profile**:
- You hold a Master´s degree in a Life Science or related discipline
- You have at least 5 years Regulatory Affairs CMC work experience within a Biotech environment
- You have gained international work experience, ideally within a Matrix driven multinational organisation
- You bring experience with biological products, preferably Monoclonal antibodies (mAb)
- You have experience in managing international regulatory submissions, BLA/MAA and LCM variations
- You have gained experience in interaction with regulatory agencies
- You have excellent spoken and written English language skills, additional languages would be a plus
- You are an excellent communicator with great interpersonal skills
- You have good organizational and planning skills
- You have a high attention to detail and the ability to work in teams
- Auf einen Blick- Standort:
- HessenBad Homburg- Karrierelevel:
- Berufserfahrene- Einsatzbereich:
- Regulatory Affairs / Safety- Arbeitsverhältnis:
- UnbefristetVollzeit- Unternehmen:
- Fresenius Kabi- Referenznummer:
- 63128- Veröffentlicht am:
- 20.09.2024- Solange die Stellenanzeige online ist, können Sie sich schnell und einfach bewerben.
-
Regulatory Affairs CMC Lead
vor 1 Monat
Bad Homburg vor der Höhe, Hessen, Deutschland FRESENIUS_KABI VollzeitJob Title:Regulatory Affairs CMC LeadJob Summary:We are seeking a highly experienced Regulatory Affairs CMC Lead to join our team at Fresenius Kabi. As a key member of our Regulatory Affairs department, you will be responsible for leading and managing CMC regulatory activities related to Biosimilars for development, initial MAA/BLA registration, and...
-
Regulatory Affairs CMC Lead
vor 2 Monaten
Bad Homburg, Deutschland FRESENIUS_KABI VollzeitFocus of the role: Lead and manage CMC regulatory activities related to Biosimilars for development, initial MAA/BLA registration and post approval life cycle management (LCM) worldwide. Define the RA-CMC strategy for the assigned programs and lead execution in close collaboration with internal and external stakeholders Your assignments As...
-
Director Regulatory Affairs Cmc
vor 5 Monaten
Pfaffenhofen an der Ilm, Deutschland Daiichi-Sankyo Europe Vollzeit**Passion for Innovation. Compassion for Patients.**: **Director Regulatory Affairs CMC (M/F/x)**: **Purpose of the function**: The Director RACMC will provide European regulatory CMC guidance and strategy for assigned products and will represent Regulatory Affairs CMC EU in internal and external interactions (e.g. global and local project teams, working...
-
Regulatory Affairs Manager
vor 4 Wochen
Marburg an der Lahn, Hessen, Deutschland Aenova IP GmbH VollzeitAufgaben und VerantwortlichkeitenAls Regulatory Affairs Manager bei Aenova IP GmbH sind Sie für die Projektbezogene Zulassungsaufgaben verantwortlich, einschließlich der konzerninternen Koordinierung der Daten- und Dokumentengewinnung. Sie planen, koordinieren und durchführen nationale und internationale Zulassungs-, Verlängerungs- und...
-
CMC Analytical Expert
vor 2 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland FRESENIUS_KABI VollzeitAbout the RoleFresenius Kabi Biosimilar Products is seeking a highly skilled CMC Analytical Expert to join our team. In this role, you will be responsible for providing analytical strategic and scientific expertise to CMC Development Teams in support of submissions to Regulatory authorities for all aspects of CMC analytical packages.Key...
-
(Senior) Manager CMC Analytical Life Cycle
vor 4 Wochen
Bad Homburg vor der Höhe, Deutschland Fresenius Kabi Deutschland GmbH VollzeitFocus of the role: Supply Analytical strategic and scientific expertise to CMC Development Teams in support of submissions to Regulatory authorities for all aspects of CMC analytical packages. Oversee and be responsible for responding to questions from regulatory authorities related to method performance, validation and transfer, stability, release...
-
Regulatory Affairs Expert
vor 3 Wochen
61352 Bad Homburg vor der Höhe, Deutschland Fresenius Medical Care Vollzeit**Your tasks**: Regulatory Documentation: - Develop, maintain, and control global regulatory product documentation (e.g., Global Technical Documentation, Registration Files) - Oversee content creation and approval of Instructions for Use (IFU), labels, and other regulatory documents - Provide guidance on compliance standards and associated testing...
-
Regulatory Affairs Manager
vor 4 Wochen
Marburg an der Lahn, Hessen, Deutschland Aenova IP GmbH VollzeitÜber uns Aenova ist eine der weltweit führenden Auftragshersteller und -entwickler für die Pharmaindustrie. Wir suchen einen erfahrenen Regulatory Affairs Manager, der unsere Zulassungs- und Compliance-Prozesse unterstützt. Ihre Aufgaben Zuständigkeit für ein definiertes Produktsortiment mit Verantwortung für die projektbezogen anfallenden...
-
Medical Affairs Lead
vor 4 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Lilly VollzeitWe're seeking a highly skilled Medical Affairs Lead to join our Oncology team at Lilly.This role will provide leadership for the Medical Affairs Team Oncology, including recruitment, team development, and departmental growth.You will be responsible for strategic development of the TA Oncology in close collaboration with Oncology BUD, IBU, and Global TA...
-
Medical Affairs Lead
vor 4 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Lilly VollzeitWe're seeking a highly skilled Medical Affairs Lead to join our Oncology team at Lilly.This role will provide leadership for the Medical Affairs Team Oncology, including recruitment, team development, and strategic planning.You will work closely with Oncology BUD, IBU, and Global TA Teams to develop and execute strategic plans for the TA Oncology.Key...
-
Regulatory Affairs Manager
vor 3 Wochen
Marburg an der Lahn, Hessen, Deutschland Aenova IP GmbH VollzeitWir suchen einen erfahrenen Zulassungsexperten für unsere Location in Marburg, Deutschland.Wenn Sie sich für die Gesundheit von Patient*innen begeistern und eigenverantwortlich wichtige Arbeit leisten möchten, dann sind wir auf der Suche nach Ihnen!Aenova, einer der führenden Auftragshersteller und -entwickler für die Pharmaindustrie, steht für...
-
Regulatory Affairs Manager
vor 4 Wochen
Bad Hersfeld, Hessen, Deutschland FRESENIUS_KABI VollzeitWir suchen eine Person, die sich auf die Regulierung von Medizinprodukten spezialisiert hat, um unsere Aufgaben im Bereich Regulatory Affairs zu unterstützen.Die Aufgaben umfassen die Verantwortung für und Unterstützung bei Projekten im Bereich Regulatory Affairs, die Bearbeitung von Kundenanfragen sowie Kundenbetreuung, die Umsetzung der...
-
Regulatory Affairs Specialist
vor 4 Wochen
Neustadt an der Donau, Bayern, Deutschland KLS Martin Group VollzeitRegulatory Affairs SpecialistWir suchen einen motivierten Regulatory Affairs Specialist, der unser Team unterstützt und sich gleichzeitig beruflich weiterentwickeln möchte. Dazu bieten wir Ihnen die Möglichkeit, berufsbegleitend ein Masterstudium Medizintechnik Regulatory Affairs an der Hochschule Furtwangen zu absolvieren. Die Finanzierung des Studiums...
-
Cmc Lead
vor 5 Monaten
Pfaffenhofen an der Ilm, Deutschland Daiichi Sankyo Europe Vollzeit**Passion for Innovation. Compassion for Patients.**: With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business is to...
-
Medical Affairs Lead
vor 4 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Lilly VollzeitWe're seeking a highly skilled Medical Affairs Lead to join our Oncology team at Lilly.As a Medical Affairs Lead, you will provide leadership for the Medical Affairs Team Oncology, recruiting new team members, developing the team, employees, and department.Key responsibilities include:Strategic development of the TA Oncology in close collaboration with...
-
Regulatory Affairs Spezialist
vor 4 Wochen
Neustadt an der Donau, Bayern, Deutschland KLS Martin Group VollzeitRegulatory Affairs SpezialistWir suchen einen motivierten Regulatory Affairs Spezialisten, der unser Team unterstützt und sich gleichzeitig beruflich weiterentwickeln möchte. Dazu bieten wir Ihnen die Möglichkeit, berufsbegleitend ein Masterstudium Medizintechnik Regulatory Affairs an der Hochschule Furtwangen zu absolvieren. Die Finanzierung des Studiums...
-
(Senior) Manager CMC Analytical Life Cycle
vor 4 Wochen
Bad Homburg, Deutschland FRESENIUS_KABI VollzeitFocus of the role: Supply Analytical strategic and scientific expertise to CMC Development Teams in support of submissions to Regulatory authorities for all aspects of CMC analytical packages. Oversee and be responsible for responding to questions from regulatory authorities related to method performance, validation and transfer, stability, release...
-
Regulatory Affairs Spezialist
vor 4 Wochen
Neustadt an der Donau, Bayern, Deutschland KLS Martin Group VollzeitKLS Martin Group ist ein global agierendes Familienunternehmen der Medizintechnik. Wir suchen einen Regulatory Affairs Spezialisten, der sich auf die Registrierung von Medizinprodukten in Japan spezialisiert hat. Die KLS Martin Group ist ein mittelständisches Unternehmen mit einer langen Geschichte im Bereich der Medizintechnik. Wir bieten eine Vielzahl von...
-
Regulatory Affairs Spezialist
vor 4 Wochen
Neustadt an der Donau, Bayern, Deutschland KLS Martin Group VollzeitUnser Team erweitern Sie als Regulatory Affairs SpezialistWir suchen einen motivierten Regulatory Affairs Spezialisten, der unser Team unterstützt und sich gleichzeitig beruflich weiterentwickeln möchte. Dazu bieten wir Ihnen die Möglichkeit, berufsbegleitend ein Masterstudium Medizintechnik Regulatory Affairs an der Hochschule Furtwangen zu absolvieren....
-
Medical Affairs Lead
vor 3 Wochen
Bad Homburg vor der Höhe, Hessen, Deutschland Lilly VollzeitWe're seeking a highly skilled Medical Affairs Lead to join our Oncology team at Lilly.Key Responsibilities:Provide leadership for the Medical Affairs Team Oncology, including recruitment, team development, and employee growth.Develop and implement strategic plans for the Oncology therapeutic area in collaboration with cross-functional teams.Collaborate with...