Regulatory CMC Product Lead
2 days ago
The Regulatory CMC Product Lead will be responsible for managing CMC regulatory activities for clinical programs, including change control procedures, out of specification management, CMC commitments and variation submissions, and product quality reviews. This contract position involves collaborating with external CMOs and managing post-submission activities.
Main Responsibilities:- Manage CMC regulatory activities for clinical programs, including authoring documents for INDs and IMPDs, responding to Health Authorities, and preparing QP release documents.
- Collaborate with external CMOs and manage post-submission activities.
- Over 10 years in CMC technical roles, with at least 5 years in lifecycle management of small molecule products.
- Pre- and post-approval CMC regulatory activities experience.
- 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, proficient in English, French is an advantage.
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Regulatory CMC Product Lead
2 days ago
Glasgow, Glasgow City, United Kingdom RBW Consulting Full timeR BW Consulting seeks an experienced Regulatory CMC Product Lead to lead CMC regulatory activities for small molecule oncology products globally. In this contract position, you will manage CMC regulatory activities for clinical programs, including change control procedures, out of specification management, CMC commitments and variation submissions, and...
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CMC Regulatory Lead
1 week ago
Glasgow, Glasgow City, United Kingdom CT19 Full timeAbout CT19">At CT19, we are committed to revolutionizing the treatment of rare diseases through cutting-edge research and innovation. Our team of experts is dedicated to delivering high-quality products that meet the needs of patients worldwide.">The Role">We are seeking an experienced Regulatory Affairs Director - CMC to join our team. As a key member of...
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CMC Regulatory Project Lead
2 days ago
Glasgow, Glasgow City, United Kingdom RBW Consulting Full timeJob OverviewWe are seeking a highly skilled CMC Regulatory Project Lead to join our team at RBW Consulting.This is a contract position until the end of March 2025, with strong likelihood of extension for a further 6-month period.The successful candidate will be responsible for overseeing regulatory activities for a small molecule oncology product...
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CMC Regulatory Specialist
2 days ago
Glasgow, Glasgow City, United Kingdom RBW Consulting Full timeJob DescriptionWe are seeking a skilled CMC Regulatory Specialist to oversee regulatory activities for small molecule oncology products globally. This contract position involves managing CMC regulatory activities for clinical programs, including change control procedures, out of specification management, CMC commitments and variation submissions, and product...
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Global Regulatory Project Manager
2 days ago
Glasgow, Glasgow City, United Kingdom RBW Consulting Full timeAbout the RoleRBW Consulting is seeking a Global Regulatory Project Manager - CMC to lead our team's efforts in managing CMC regulatory activities for clinical programs. This role involves overseeing change control procedures, out of specification management, CMC commitments and variation submissions, and product quality reviews.Main Responsibilities:Lead...
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CMC Regulatory Project Manager
3 days ago
Glasgow, Glasgow City, United Kingdom RBW Consulting Full timeAs a seasoned CMC Regulatory Project Manager at RBW Consulting, you will oversee regulatory activities for small molecule oncology products globally. This contract position involves managing CMC regulatory activities for clinical programs, including change control procedures, out of specification management, CMC commitments and variation submissions, and...
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Senior Regulatory CMC Manager
2 days ago
Glasgow, Glasgow City, United Kingdom RBW Consulting Full timeJob DescriptionWe are seeking a highly experienced Senior Regulatory CMC Manager to join our team at RBW Consulting.This is a contract position until the end of March 2025, with strong likelihood of extension for a further 6-month period.The successful candidate will be responsible for managing regulatory activities for a small molecule oncology product...
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Global CMC Compliance Specialist
3 days ago
Glasgow, Glasgow City, United Kingdom RBW Consulting Full timeIn this exciting opportunity as a Global CMC Compliance Specialist at RBW Consulting, you will be responsible for overseeing regulatory activities for small molecule oncology products globally. You will manage CMC regulatory activities for clinical programs, including change control procedures, out of specification management, CMC commitments and variation...
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Global Oncology Regulatory Specialist
3 days ago
Glasgow, Glasgow City, United Kingdom RBW Consulting Full timeAbout the RoleWe are looking for a seasoned Global Oncology Regulatory Specialist to join our team at RBW Consulting.This is a contract position until the end of March 2025, with strong likelihood of extension for a further 6-month period.The successful candidate will be responsible for leading regulatory activities for a small molecule oncology product...
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Regulatory Compliance Lead
6 days ago
Glasgow, Glasgow City, United Kingdom The FMC Network Full timeJob Title: Regulatory Compliance LeadThe FMC Network is seeking a highly skilled Regulatory Compliance Lead to oversee our regulatory compliance efforts across all water treatment and water hygiene services. This is an exciting opportunity to join a dynamic team and contribute to shaping the future of our organization.**Key Responsibilities:**Ensure...
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Regulatory Compliance Lead
6 days ago
Glasgow, Glasgow City, United Kingdom HRC Recruitment Careers Full timeRegulatory Reporting & Oversight Manager">We are seeking an experienced compliance professional to lead a high-performing team and drive key compliance initiatives. The successful candidate will report directly to the Head of Internal Control, Compliance & Legal Relay.">This pivotal role offers an exciting opportunity to develop new frameworks to monitor...
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Regulatory Reporting Lead
2 days ago
Glasgow, Glasgow City, United Kingdom HRC Recruitment Full timeAbout the RoleThis pivotal position reports directly to the Head of Internal Control, Compliance & Legal Relay and offers an exciting opportunity to lead a high-performing team while driving key compliance initiatives.Key ResponsibilitiesEnsure accurate and timely submission of regulatory reports.Utilize existing reporting tools and develop new frameworks to...
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Regulatory Advisor
6 days ago
Glasgow, Glasgow City, United Kingdom Barclays Full timeAs a leading global bank, Barclays is seeking an exceptional Regulatory Advisor to join its team. The successful candidate will have a strong background in payments regulation and experience with relevant financial services products.This role offers a unique opportunity to provide regulatory advice, transactional support, and product management. Key...
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Regulatory Compliance Analyst
1 month ago
Glasgow, Glasgow City, United Kingdom Barclays Full timeAbout the RoleWe are looking for a talented Regulatory Compliance Analyst to join our team at Barclays. In this role, you will be responsible for identifying, assessing, and mitigating prudential regulatory reporting risks, providing oversight on regulatory reporting, and maintaining open communication with regulators.Your Key Responsibilities:Identify and...
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Product Innovation Lead
1 week ago
Glasgow, Glasgow City, United Kingdom Austin Fraser Full timeJob OverviewAustin Fraser is seeking a highly skilled New Product Development Manager to drive the company's product offerings to the next level. This dynamic role involves overseeing the entire product development lifecycle, from concept to delivery.Key Responsibilities:Lead and manage cross-functional teams to deliver new product lines on time and within...
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Compliance and Regulatory Professional
1 week ago
Glasgow, Glasgow City, United Kingdom CV-Library Full timeJob Description:CV-Library is seeking a highly skilled Regulatory Affairs Officer to join our team on a permanent basis. As a key member of our team, you will be responsible for ensuring that our products meet all regulatory requirements.Key Responsibilities:Prepare and compile regulatory documentationCoordinate and execute regulatory submissionsDevelop...
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Regulatory Compliance Officer
6 days ago
Glasgow, Glasgow City, United Kingdom Barclays UK Full timeCareer OpportunityWe are seeking a seasoned Legal Counsel to lead our Regulatory Compliance team at Barclays UK. This exciting opportunity offers the chance to shape our regulatory strategy and drive innovation in cash management and payments.As a key member of our leadership team, you will be responsible for developing and executing regulatory compliance...
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Regulatory Compliance Specialist
3 days ago
Glasgow, Glasgow City, United Kingdom HRC Recruitment Full timeJob TitleRegulatory Compliance SpecialistWe are seeking an experienced compliance professional to join HRC Recruitment's client, a leading organisation in their sector. The Regulatory Compliance Specialist will report directly to the Head of Internal Controls.This pivotal role is responsible for ensuring excellence in regulatory reporting and oversight. As a...
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Regulatory Compliance Specialist
1 week ago
Glasgow, Glasgow City, United Kingdom HRC Recruitment Full timeJob OverviewWe are seeking an experienced Regulatory Reporting & Oversight Manager to join our client, a leading organisation in their sector. This pivotal role reports directly to the Head of Internal Controls and will be responsible for ensuring excellence in regulatory reporting and oversight.The successful candidate will have a strong understanding of...
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Regulatory Compliance Specialist
1 day ago
Glasgow, Glasgow City, United Kingdom HRC Recruitment Full timeJob Title: Regulatory Reporting & Oversight ManagerAbout the RoleThe Regulatory Reporting & Oversight Manager will be responsible for ensuring all regulatory reporting is accurate and timely, both internally and with external bodies such as the FCA, FLA, and ICO. This role also involves managing the Oversight Analysts team, ensuring that the oversight...