Regulatory Cmc Project Manager
1 month ago
Regulatory CMC Project Manager - Contract Partnering with an international pharmaceutical company focused on both in house product development and CDMO services, we are now supporting the appointment of a new Regulatory CMC Project Manager to oversee regulatory activities for a small molecule oncology product globally.
This position will be a contract until the end of March 2025, with strong likelihood of extension for a further 6 month period.
This role involves working independently and with an outsourcing team on tasks such as change controls, out of specification assessments, PQRs, and clinical phase activities.
Key responsibilities: Change control procedures Out of specification management CMC commitments and variation submissions Product Quality Review (PQR) production and review Collaboration with external CMOs Manage CMC regulatory activities for clinical programs, including: Authoring INDs and IMPDs Responding to Health Authorities Preparing documents for QP release Post-submission management Key Experience: Over 10 years in CMC technical roles, with at least 5 years in lifecycle management of small molecule products Experience in pre- and post-approval CMC regulatory activities Effective stakeholder management Project management within a CMC context Knowledge of IND/NDA and IMPD/MAA formats Understanding of drug substance and product CMC Organized, independent, and able to manage multiple activities Degree in Pharmacy or a relevant science/technical subject Language skills: Proficient in English, French is an advantage Regulatory, CMC, project, manager, small, molecule, IND, IMPD, PQR, change, control, quality, assurance, RA, affairs, submission, oncology, cancer, therapy, MAA, marketing, authorisation
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Regulatory CMC Project Lead
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Ledston, United Kingdom Rbw Consulting Full timeRBW Consulting is seeking a skilled Regulatory CMC Project Manager to oversee regulatory activities for small molecule oncology products globally. The ideal candidate will have over 10 years of experience in CMC technical roles, with at least 5 years in lifecycle management of small molecule products.The salary for this position is estimated to be around...
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CMC Regulatory Project Lead
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Ledston, United Kingdom Rbw Consulting Full timeRBW Consulting is seeking a highly experienced CMC Regulatory Project Lead to oversee regulatory activities for small molecule oncology products globally. The successful candidate will work independently and collaboratively with an outsourcing team on tasks such as change controls, out of specification assessments, PQRs, and clinical phase activities.This...
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Regulatory CMC Project Manager
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Ledston, United Kingdom Rbw Consulting Full timeAt RBW Consulting, we are seeking a highly experienced CMC Regulatory Specialist Lead to oversee regulatory activities for small molecule oncology products globally. This is an independent role that involves managing tasks such as change controls, out of specification assessments, PQRs, and clinical phase activities.The ideal candidate will have over 10...
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CMC Regulatory Expert Manager
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Ledston, United Kingdom Rbw Consulting Full timeR BW Consulting is looking for a Regulatory CMC Project Manager to lead our team in managing CMC regulatory activities for clinical programs. As a key member of our team, you will work independently and with an outsourcing team on tasks such as change controls, out of specification assessments, PQRs, and clinical phase activities.The successful candidate...
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CMC Regulatory Specialist Lead
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Ledston, United Kingdom Rbw Consulting Full timeWe are looking for a skilled Small Molecule Oncology Product Manager to join our team at RBW Consulting. As a key member of our organization, you will be responsible for managing CMC regulatory activities for clinical programs, including change control procedures, out of specification management, CMC commitments, and variation submissions.The successful...
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Regulatory CMC Manager
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Ledston, United Kingdom Rbw Consulting Full timeAs a Regulatory CMC Manager - Oncology, you will play a key role in ensuring compliance with regulatory requirements for our clients' small molecule oncology products.Your responsibilities will include managing CMC regulatory activities for clinical programs, authoring documents for INDs and IMPDs, responding to Health Authorities, and preparing QP release...
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Senior Life Cycle Management Specialist
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Small Molecule Oncology Product Manager
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Ledston, United Kingdom Rbw Consulting Full timeR BW Consulting is seeking a talented Regulatory CMC Project Manager to lead our regulatory activities for small molecule oncology products globally. This is an exciting opportunity to work independently and collaborate with an outsourcing team on tasks such as change controls, out of specification assessments, PQRs, and clinical phase activities.The ideal...
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