Regulatory Affairs Cmc Lead

vor 2 Monaten

Bad Homburg vor der Höhe, Deutschland Fresenius Kabi Vollzeit

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 3 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland FRESENIUS_KABI Vollzeit

    Job 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 3 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland FRESENIUS_KABI Vollzeit

    Job SummaryWe are seeking a highly skilled Regulatory Affairs CMC Lead to join our team at FRESENIUS KABI. As a key member of our regulatory affairs team, you will be responsible for leading and managing CMC regulatory activities related to biosimilars for development, initial MAA/BLA registration, and post-approval life cycle management worldwide.Key...

  • Regulatory Affairs CMC Lead

    vor 3 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland FRESENIUS_KABI Vollzeit

    Job SummaryWe are seeking a highly skilled Regulatory Affairs CMC Lead to join our team at FRESENIUS KABI. As a key member of our regulatory affairs team, you will be responsible for leading and managing CMC regulatory activities related to biosimilars for development, initial MAA/BLA registration, and post-approval life cycle management worldwide.Key...

  • Regulatory Affairs CMC Lead

    vor 1 Monat

    Bad Homburg vor der Höhe, Hessen, Deutschland FRESENIUS_KABI Vollzeit

    Job SummaryWe are seeking a highly skilled Regulatory Affairs CMC Lead to join our team at FRESENIUS KABI. As a key member of our regulatory affairs team, you will be responsible for leading and managing CMC regulatory activities related to biosimilars for development, initial MAA/BLA registration, and post-approval life cycle management worldwide.Key...

  • Regulatory Affairs CMC Lead

    vor 1 Monat

    Bad Homburg vor der Höhe, Hessen, Deutschland FRESENIUS_KABI Vollzeit

    Job SummaryWe are seeking a highly skilled Regulatory Affairs CMC Lead to join our team at FRESENIUS KABI. As a key member of our regulatory affairs team, you will be responsible for leading and managing CMC regulatory activities related to biosimilars for development, initial MAA/BLA registration, and post-approval life cycle management worldwide.Key...

  • Regulatory Affairs CMC Lead

    vor 2 Monaten

    Bad Homburg vor der Höhe, Hessen, Deutschland FRESENIUS_KABI Vollzeit

    Job SummaryWe are seeking a highly skilled Regulatory Affairs CMC Lead to join our team at FRESENIUS_KABI. As a key member of our regulatory team, you will be responsible for leading and managing CMC regulatory activities related to Biosimilars for development, initial MAA/BLA registration, and post-approval life cycle management worldwide.Key...

  • Regulatory Affairs CMC Lead

    vor 2 Monaten

    Bad Homburg vor der Höhe, Hessen, Deutschland FRESENIUS_KABI Vollzeit

    Job SummaryWe are seeking a highly skilled Regulatory Affairs CMC Lead to join our team at FRESENIUS_KABI. As a key member of our regulatory team, you will be responsible for leading and managing CMC regulatory activities related to Biosimilars for development, initial MAA/BLA registration, and post-approval life cycle management worldwide.Key...

  • Regulatory Affairs CMC Lead

    vor 2 Monaten

    Bad Homburg, Deutschland FRESENIUS_KABI Vollzeit

    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...

  • 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 2 Wochen

    Marburg an der Lahn, Hessen, Deutschland Aenova IP GmbH Vollzeit

    Aufgaben 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 3 Tagen

    Bad Homburg vor der Höhe, Hessen, Deutschland FRESENIUS_KABI Vollzeit

    About 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...

  • Medical Affairs Lead

    vor 3 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Lilly Vollzeit

    Join Our Team as a Medical Affairs Lead in OncologyWe're seeking a highly skilled Medical Affairs Lead to join our Oncology team at Lilly. As a key member of our team, you will be responsible for providing leadership and strategic direction to our Medical Affairs team in Oncology.Key Responsibilities:Lead the Medical Affairs team in Oncology, including...

  • Medical Affairs Lead

    vor 3 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Lilly Vollzeit

    Join Our Team as a Medical Affairs Lead in OncologyWe're seeking a highly skilled Medical Affairs Lead to join our Oncology team at Lilly. As a key member of our team, you will be responsible for providing leadership and strategic direction to our Medical Affairs team in Oncology.Key Responsibilities:Lead the Medical Affairs team in Oncology, including...

  • Medical Affairs Lead

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Lilly Vollzeit

    Join Our Team as a Medical Affairs Lead in OncologyWe're seeking a highly skilled Medical Affairs Lead to join our Oncology team at Lilly. As a key member of our team, you will be responsible for providing leadership and strategic direction to our Medical Affairs team in Oncology.Key Responsibilities:Provide leadership and guidance to the Medical Affairs...

  • Medical Affairs Lead

    vor 4 Wochen

    Bad Homburg vor der Höhe, Hessen, Deutschland Lilly Vollzeit

    Join Our Team as a Medical Affairs Lead in OncologyWe're seeking a highly skilled Medical Affairs Lead to join our Oncology team at Lilly. As a key member of our team, you will be responsible for providing leadership and strategic direction to our Medical Affairs team in Oncology.Key Responsibilities:Provide leadership and guidance to the Medical Affairs...

  • Medical Affairs Lead

    vor 1 Monat

    Bad Homburg vor der Höhe, Hessen, Deutschland Lilly Vollzeit

    Join Our Team as a Medical Affairs Lead in OncologyWe're seeking a highly skilled Medical Affairs Lead to join our Oncology team at Lilly. As a key member of our team, you will be responsible for providing leadership and strategic direction to our Medical Affairs team in Oncology.Key Responsibilities:Lead the Medical Affairs team in Oncology, driving...

  • Medical Affairs Lead

    vor 1 Monat

    Bad Homburg vor der Höhe, Hessen, Deutschland Lilly Vollzeit

    Join Our Team as a Medical Affairs Lead in OncologyWe're seeking a highly skilled Medical Affairs Lead to join our Oncology team at Lilly. As a key member of our team, you will be responsible for providing leadership and strategic direction to our Medical Affairs team in Oncology.Key Responsibilities:Lead the Medical Affairs team in Oncology, driving...

  • (Senior) Manager CMC Analytical Life Cycle

    vor 2 Wochen

    Bad Homburg vor der Höhe, Deutschland Fresenius Kabi Deutschland GmbH Vollzeit

    Focus 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 2 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...

  • Drug Regulatory Affairs Specialist

    vor 1 Monat

    Neumarkt in der Oberpfalz, Bayern, Deutschland Bionorica Vollzeit

    Job Title: Drug Regulatory Affairs OfficerBionorica, a global leader in the development and manufacturing of plant-based pharmaceuticals, is seeking a highly skilled Drug Regulatory Affairs Officer to join our team.Key Responsibilities:Prepare and submit regulatory documents for pharmaceutical products, including dossiers, labels, and packaging...