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Senior Manager
1 week ago
AJ Chambers London, United Kingdom**Senior Manager / Director / PA to Partner - Route to Partnership** · This is a fantastic role for an individual at Senior Manager / Director level, looking to join a growing firm with opportunities for Partnership. · If successful, you will work directly for the Managing Partne ...
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Senior Manager
2 days ago
Ambition Europe Limited London, United Kingdom**Senior Manager - Audit Quality Assurance** · Join this Top 10 firm based in London, to further your Audit career and be in a more technical role, overseeing the quality side of the piece. · Not only is this a Top 10 firm in general, but they're one of the best firms out there w ...
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Senior Manager
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Warner Scott Recruitment Ltd London, United KingdomManager / Senior Manager - (medium sized West End firm in London) - up to £85k · Nine partner private client firm of Chartered Accountants in the West End seeks to recruit a qualified ACA or ACCA with more than five years post qualification experience. · The role is an audit and ...
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Senior Manager
1 week ago
Morgan McKinley London, United KingdomAre you an Audit Manager or Senior Audit Manager (ideally with RI status) who is looking to work for one of the fastest growing firms in the UK? · I am currently working alongside a top 100 firm in Central London who have recently received a significant amount of private equity i ...
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Senior Manager
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Senior Manager
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ONETEN ASSOCIATES LIMITED London, United Kingdom_A leading service provider in London is looking to identify someone at Senior Manager Level to mange the company secretarial services and investor services for their large portfolio of Private Equity and Real Estate Clients_ · - A brilliant opportunity has arisen in our client's ...
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Senior Manager
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eFinancialCareers London, United Kingdom**Your new company** · Global Corporate and Fund services business for Private Equity, infrastructure and Real Estate require a Senior Corporate Accounting Manager to take responsibility for a portfolio of Real Estate clients and running a team. · **Your new role** · Responsible ...
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eFinancialCareers London, United KingdomWe've been retained for a search on behalf of a global law firm who have recently appointed a heavyweight global head to launch a regulatory consulting practice as part of the firms wider offering - the team advise the law firms regulated clients (PRA /FCA) clients globally in al ...
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Senior Manager
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Morgan McKinley London, United KingdomAre you an Audit Manager or Senior Manager who holds RI status and has worked with clients in the Banking sector? · I am currently working with a global Accountancy firm, headquartered abroad, who are looking to hire an Audit Senior Manager on a part time or full time basis in or ...
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Senior Manager
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Senior Manager
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CMC Consulting Limited London, United KingdomA fast expanding advisory firm are looking to expand their highly performing M&A team. Offering full service advisory you will get to work across a range of exciting sectors making this a dynamic and fluid role. Working within a fantastic culture you willbuild your network and le ...
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Senior Manager
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Senior Manager
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eFinancialCareers London, United KingdomA leading Financial Risk & RegTech Consultancy is hiring a Senior Manager to join a quickly growing team. This position will suit a Senior Manager with proven experience in asset management, advising funds, private equity, corporate finance and/or insurancefirms. · As a Senior Ma ...
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Senior Manager
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Harnham - Data & Analytics Recruitment London, United Kingdom**SENIOR MANAGER - CRM RETENTION** · **LONDON** · **£85,000-£95,000 +BONUS +BENEFITS** · **THE COMPANY** · This company is one of the leading challenger banks and known as a market disruptor. They were founded over 10 years ago and have over 4 million customers. This role focuses ...
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Senior Manager
1 week ago
eFinancialCareers London, United Kingdom**Newly Created Senior Finance Accounting Manager role at Leading Corporate Management Company** · Job Title: Senior Manager · Duration: Permanent · Location: City of London (50/50 WFH) · A global, publicly traded, corporate management company are looking for a new senior manager ...
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Senior Manager
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Senior Manager
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Pod Talent London, United Kingdom_This world-renowned Pharma brand is known for their innovation and agility in an ever-evolving market. With patient care at the heart of what they do, the procurement and sourcing team works on complex projects to help challenge the boundaries of healthcareand aid in the new dev ...
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Senior Manager
2 days ago
Lloyds Banking Group London, United KingdomEnd Date · Salary Range · Agile Working Options · Flexible / Variable Hours · Job Description Summary · Lead the implementation of data risk initiatives under the Data and Analytics Strategy supporting business units across LBG in the assessment, measurement, and management of da ...
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Senior Manager
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BCT Resourcing London, United KingdomSenior Manager, Financial Reporting · London/ hybrid · Salary £90-100,000 per annum, DoE · New Permanent Role · I am currently working with a Lloyd's insurer looking for an accountant with strong UK GAAP reporting experience to join their team and lead the financial reporting fun ...
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Senior Manager
1 week ago
eFinancialCareers London, United KingdomA great opportunity has arisen for a Senior Manager to play a central role in the firm's Audit Quality Assurance Review process and related activities as part of the Quality & Risk Management team, working with a market leading global consulting firm.In the continually changing a ...
Drug Product, Senior Manager - England, United Kingdom - The RFT Group
Description
Drug Product Senior Manager / ManagerOur client is an exciting, rapid growing publicly listed clinical stage biopharmaceutical business focussed on establishing best in class teams across all its functions.
To date, the company has raised $300 million +, and is engaged in a major expansion of its team in Ireland.
The main task of the Manager, Drug Product, is to lead projects from the technical feasibility evaluation through commercial registration of the company drug product portfolio.
The preferred candidate will have experience of drug product formulation for inhaled products in combination with drug product development as well as strong vendor management.
This role can be remote within in Europe, the UK or the US.Job Spec Develop and execute the strategy for development and clinical study production of company drug products in alignment with company goals and clinical plans.
Oversee all CMC-DP for inhalation combination drug product related activities with vendors:formulation and process development for use with device, technical transfer; scale-up; control strategy build, and implementation; PPQ.Ensure all DP-related processes are in line with health, safety, environmental and quality requirements including regulations, policies, applicable guidelines and procedures.
Develop and control appropriate budgets and timelines for the delivery of CMC-DP in line with company goals.Review and approval (technical approval) of all analytical data, development reports and protocols, work orders and quotes related to CMC- DP.Summarize and present CMC-DP, development plans, activities and outputs to management or other departments in support of product development.
Responsible for providing CMC-DP and Combination product-related regulatory documents such as product development reports for regulatory filings, inclusive of management, reviewing, updating and authoring.
Management of CMOs, scientific advisors, regulatory advisors as needed to achieve CMC-DP goals.Assisting in defining regulatory strategies both towards FDA, EMA and required markets.
Provide Leadership and Expertise in Inhalation Drug product development and analysis/testing as an SME in the field.
Liaise with other CMC functions including Drug Substance, Analytical and Engineering/Device to provide technical support in establishment of specifications and analytical methodology.
Support device regulated development and required DP assistance to device and combination product development activities.Provide data interpretation and perform data trending and monitoring using statistical methods as appropriate.
Support URS and PURs of manufacturing equipment along with supporting installation and process qualification.
Support the identification and selection of suitable drug product development and commercial manufacturing vendors (CMOs).Develop knowledge and create IP opportunities for the portfolio.
Person SpecMinimum 8 to 10 years' experience as a drug project manager in a pharmaceutical and/or biotech company or CRO.Experience on CMC documentation for respiratory devices is important.
Experience in Drug product development from early to late stage inclusive of GMP/clinical supply manufacture.Experience with regulatory documentation for CMC activities on drug substance, drug product both towards FDA and EMA is mandatory.
Solid experience with working in a regulated environment under GxP and with adherence to Company SOPs, policies and guidelines.
Updated knowledge of ICH GMP is required.
Excellent communication, presentation, and interpersonal skills. Self-driven and motivated team player. Familiar with working in a virtual set-up. Fluent in written and spoken professional English. CV to Gerry Kennedy at /