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Job Title: Global Regulatory Lead (GRL), Senior Regulatory Program Manager Job Type: Full-time permanent position Location: West London, UK – 3x a week in the office Salary: Attractive salary plus benefits package Working for one of the industry’s leading pharmaceutical companies, this is a fantastic opportunity to provide expert regulatory knowledge from pre-clinical through clinical studies to initial registration in key global markets. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval of new drugs, biologics/biotechnology, and/or medical devices, and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations, and interpretations. Coordinates, reviews, and may prepare reports for submission. Role responsibilities: • Drive global Regulatory Affairs strategies for the portfolio, including managing internal and external stakeholders., • Lead interactions with the health authorities/ local agencies – MHRA, EMA & FDA. This will be including pre-submission meetings, pre-IND meetings, Scientific advice and type B/C meetings with the FDA., • Support both early and late-stage development activities CTAs, IND, ODD, PIPS, IND, IMPD, and initial MAAs., • Confident in doing submissions in global markets with a main focus on the UK, EU, US, and ROW., • Support and lead cross functional team discussions with medical, quality, PV, and other departments. Requirements: • A scientific degree is essential., • Proven track record of leading successful European (CP, DCP, MRP), European national and US submissions., • Confident in leading global RA strategies., • Knowledge of regulatory frameworks and external environments as it applies to project specific global regulatory strategy document (GRSD) delivery., • Ability to drive new regulatory approaches to improve and expedite development products submissions to meet business/project objectives and patient needs., • Ability to clearly convey and exchange information with internal and external stakeholders. This role is a very senior role within the regulatory team and within any other business, it may be titled an Associate Director. You will need at least 8 years of relevant regulatory experience, ideally within a large pharmaceutical business. All the Regulatory team members attend the office 3x a week, so you would be expected to attend the office on a hybrid basis in White City, London. For more information, please reach out to me at

Established in 1997 as the first manufacturer of sushi for the UK supermarket industry, Taiko has evolved into the most innovative manufacturer of Sushi, Food To Go, Prepared Meals and Snacking products in the UK, supplying Waitrose, Tesco and Sainsbury’s to name a few. Over the past 25 years Taiko has launched more first to market Sushi and Food to Go products than any other sushi manufacturer in the UK. The role of the Specification Technologist is to ensure legal compliance and safety of products and packaging through the preparation, maintenance and management of specifications for raw materials, finished products and packaging materials, product labels and other printed packaging, artwork, and all related documents. The Role of Specifications Technologist reports to the Specification Manager. • You’ll have a strong customer focus with the ability to communicate with customers on a routine basis, • You’ll have the ability to work within a team and with other departments, demonstrate a flexible approach to work and manage time-critical assignments that involve varying degrees of complexity, • You’ll need good English comprehension, good written and spoken English and be able to understand and interpret regulations and produce work that is accurate and concise., • Attention to detail and accuracy of documents is a crucial pre-requisite to be successful in the role, • The role requires good computer skills and working knowledge of customer website management. In particular Waitrose Principal Responsibilities, • To create, manage and maintain the specifications for each and every product produced by Taiko Foods., • To source, manage and maintain the specifications for each and every ingredient, raw material, and item of packaging used by Taiko Foods. Ensure the accuracy and legality of all documents., • To manage customer specific websites and database; advise the business of policy document updates and summarise for distribution within the business, customer questionnaires as required., • To facilitate the creation and project management of packaging artwork and label copy for new products and changes to existing products. Ensure the legality and accuracy of information as part of the sign off procedure., • To manage the approved label database and upload data as required that supports the finished product labelling operation., • To liaise with the NPD technologist in order to ensure all NPD projects are completed successfully., • To conduct the supplier risk assessment and approval process and maintain approved supplier registers. Ensuring that all information is accurate, up to date and appropriate to enable management of the risk posed by each supplier., • To conduct ingredients and packaging risk assessments and approval process and maintain the approved ingredient and packaging registers., • Actively support the allergen management system and contribute to the HACCP management system as required To ensure processes, procedures and risk assessments are managed and maintained in compliance with BRC requirements., • As required to achieve the Principal Responsibilities, • As required to support the objective

Previous experience as a technical maintenance technician, technical manager or with diagnostic and maintenance skills is an advantage. Collaborate with technical engineers to collect and document automotive technical cases. Provide support for skills competitions and other technical activities rela

Receive and/or download electronic drawings and documents, file as appropriate and maintain a document register. Our Programme Solutions team encompasses 60+ Programme Management, Project Controls, Risk Managers, Planning professionals and Document Controllers with differing backgrounds and seniorit

Receive and/or download electronic drawings and documents, file as appropriate and maintain a document register. You will be working within a team and undertaking document and information management across a range of high-profile engineering projects. Issue drawings and documents in accordance with

What you’ll be doing as a Document Manager. You will support the Thames Water (TW) SRO Portfolio team in client-side document management, under the guidance of the Senior Information Manager and aligned with the SRO Digital Strategy. Experience creating templates and guidance documents.

Care Assistant - Nights - Elstree.At Avery Healthcare, we are all about supporting the people who care for our residents.We know how hard our teams work, and we're here to celebrate and support you every step of the way.When you join us, you'll be making a positive impact on residents' lives every

Receive and/or download electronic drawings and documents, file as appropriate and maintain a document register. Our Programme Solutions team encompasses 60+ Programme Management, Project Controls, Risk Managers, Planning professionals and Document Controllers with differing backgrounds and seniorit

Senior Care Assistant - Nights - Chorleywood.At Avery Healthcare, we are all about supporting the people who care for our residents.We know how hard our teams work, and we're here to celebrate and support you every step of the way.When you join us, you'll be making a positive impact on residents' l

Are you passionate about technical migrations of clinical documents? Are you seeking innovative opportunities to apply your expertise across large, diverse clinical trial migrations and BD&L TMF integration projects? If so, then the CDM Business Migrations Manager position within the Clinical Docume

At Avery Healthcare, we are all about supporting the people who care for our residents.We know how hard our teams work, and we're here to celebrate and support you every step of the way.When you join us, you'll be making a positive impact on residents' lives every day - your compassion and dedicatio

As a Document Manager, you’ll be supporting the Thames Water (TW) Strategic Resource Option (SRO) Portfolio team to deliver Client-side Document Management under the direction of the Senior Information Manager and in the frame with the SRO Digital Strategy. The Document Manager is responsible for

Care Assistant - Nights - Chertsey.At Avery Healthcare, we are all about supporting the people who care for our residents.We know how hard our teams work, and we're here to celebrate and support you every step of the way.When you join us, you'll be making a positive impact on residents' lives every

In partnership with HP & Xerox, we deliver cutting-edge document and print solutions.

How would you like to get paid for five days, but only work four?.At Outcomes First Group, we believe in better work/life balance — and we’re putting wellbeing first.That’s why we’re proud to be part of a 4-Day Working Week (4DWW) trial, where you can work one day less each week (or equivale

Our Programme Solutions team encompasses 60+ Programme Management, Project Controls, Risk Managers, Planning professionals and Document Controllers with differing backgrounds and seniority, based across the UK. Receive and/or download electronic drawings and documents, file as appropriate and mainta

Love being on the move and interacting with people from all walks of life? Proud to deliver quality goods on time and put a smile on thousands of faces every week?.Join Ocado Logistics where there are bags of possibilities.It's our mission to provide an outstanding customer experience.Whilst others

As a Document Manager, you’ll be supporting the Thames Water (TW) Strategic Resource Option (SRO) Portfolio team to deliver Client-side Document Management under the direction of the Senior Information Manager and in the frame with the SRO Digital Strategy. The Document Manager is responsible for

How would you like to get paid for five days, but only work four?.At Outcomes First Group, we believe in better work/life balance — and we’re putting wellbeing first.That’s why we’re proud to be part of a 4-Day Working Week (4DWW) trial, where you can work one day less each week (or equivale

As a Document Manager, you’ll be supporting the Thames Water (TW) Strategic Resource Option (SRO) Portfolio team to deliver Client-side Document Management under the direction of the Senior Information Manager and in the frame with the SRO Digital Strategy. The Document Manager is responsible for

How would you like to get paid for five days, but only work four?.At Outcomes First Group, we believe in better work/life balance — and we’re putting wellbeing first.That’s why we’re proud to be part of a 4-Day Working Week (4DWW) trial, where you can work one day less each week (or equivale

Get notified about new Document Control Manager jobs in. Assist in preparing and managing documentation internally/by subcontractor. Ability to spot errors in documents, such as formatting errors, typos, or similar.

How would you like to get paid for five days, but only work four? At Outcomes First Group, we believe in better work/life balance — and we’re putting wellbeing first.That’s why we’re proud to be part of a 4-Day Working Week (4DWW) trial, where you can work one day less each week (or equivale

As a Document Control Manager, you will manage client and stakeholders document control activity, implement and control policies & procedures to capture, store, protect, share, distribute and manage project information. Use client-based document control systems for issuing and receiving documents an

How would you like to get paid for five days, but only work four?.At Outcomes First Group, we believe in better work/life balance — and we’re putting wellbeing first.That’s why we’re proud to be part of a 4-Day Working Week (4DWW) trial, where you can work one day less each week (or equivale

Receive and/or download electronic drawings and documents, file as appropriate and maintain a document register. Our Programme Solutions team encompasses 60+ Programme Management, Project Controls, Risk Managers, Planning professionals and Document Controllers with differing backgrounds and seniorit

How would you like to get paid for five days, but only work four? At Outcomes First Group, we believe in better work/life balance — and we’re putting wellbeing first.That’s why we’re proud to be part of a 4-Day Working Week (4DWW) trial, where you can work one day less each week (or equivale

Good knowledge of quality and legal obligations with respect to document control, and an understanding of audit trails for project documentation through the lifecycle. Document Control Manager – UK Atomic Energy Authority. The role involves end-to-end delivery of H3AT Plant project documentation a

Housekeeping Assistant - Care Home - Epsom.As a Housekeeping Assistant at a Barchester care home, you'll help to create a warm and homely environment that enables us to meet each resident's unique needs.Keeping the home clean and safe is no small task, which is why the role of Housekeeping Assistant

Documented evidence of eligibility will be required from candidates as part of the recruitment process.

Housekeeping Assistant - Bank - Care Home - Wilton.As a Bank Housekeeping Assistant at a Barchester care home, you'll help to create a warm and homely environment that enables us to meet each resident's unique needs.Keeping the home clean and safe is no small task, which is why the role of a Bank Ho

Social Care Assistant, St brendan's Care Home, Isle of Barra (0924).You will work enthusiastically as a member of a team that promotes and supports Adults with Support Needs to actively take part within local resources and facilities, to maximise their inclusion, independence and planned outcomes.Th

As a Cleaner for Tenpin, you will be responsible for ensuring our Customers have an.When it comes to keeping your site spick and span, we will need you to bring your 'A' game.We love to entertain! It's in our DNA!.We have lots more to offer from Houdini's Escape Rooms, to Karaoke rooms, 4D Laser Are

Social Care Assistant, St brendan's Care Home, Isle of Barra (9324).You will work enthusiastically as a member of a team that promotes and supports Adults with Support Needs to actively take part within local resources and facilities, to maximise their inclusion, independence and planned outcomes.Th

Maintenance Assistant - Bank - Care Home - Horndean.As a Bank Maintenance Assistant at a Barchester care home, you'll help to create the safe and attractive surroundings that will enable us to give our patients the quality care and support they deserve.It's important that our homes give the right fi

UK, to businesses based in Hampshire and Surrey.Apply fast, check the full description by scrolling below to find out the full requirements for this role.You will be required to undertake dedicated express courier deliveries across the country in a Mercedes Sprinte.

Join our team at Thornwick Bay nestled near the historic village of Flamborough in East Yorkshire.North Marine Road, Flamborough, East Yorkshire YO15 1AU GBR.Part-Time / Seasonal - working Mondays and Fridays.Join our One Great Team here at Haven as an Accommodation Cleaner.We're looking for reliabl

Self-employed Core Delivery Driver.As one of our Self-Employed Core Delivery Drivers you'll enjoy freedom, flexibility and better financial rewards, plus all the support and benefits of being part of our wider Yodel team.You don't need any experience, and the more you deliver, the more you earn.Comp

As a Receptionist at a Barchester care home, you'll provide the warm welcome that helps to make sure every resident and visitor feels at home with us.As the first point of contact for almost everyone who comes to the home, you'll have a vitally important part to play in creating a positive and frien

Exciting Delivery Associate/Driver Opportunity in Your Area - Immediate Start!.Discover an incredible chance to become a part of our network as a Delivery Associate/Driver, offering an immediate start right in your area.If you're eager to join a dynamic business where you can both enjoy your work an

Exciting Delivery Associate/Driver Opportunity in Your Area - Immediate Start!.Discover an incredible chance to become a part of our network as a Delivery Associate/Driver, offering an immediate start right in your area.If you're eager to join a dynamic business where you can both enjoy your work an

All potential candidates should read through the following details of this job with care before making an application.Sector: Manufacturing Non-Food.Own vehicle essential due to site location and shift times.Experienced Forklift Driver Required!.ISQ Recruitment is working with a well-established man

As a Bank Care Assistant at a Barchester care home, you'll help residents enjoy each day by making sure they get the quality care and support they deserve.You'll assist with daily living, providing support and companionship and sharing great moments and memories too.It's a chance to bring your dedi

We are looking to recruit an enthusiastic and motivated Senior Support Worker, with the commitment and positive attitude to work alongside a Project Manager to support and supervise a dedicated staff team and deliver high quality support to adults in supported living settings at our Durham Services.

Exciting Delivery Associate/Driver Opportunity in Your Area - Immediate Start!.Discover an incredible chance to become a part of our network as a Delivery Associate/Driver, offering an immediate start right in your area.If you're eager to join a dynamic business where you can both enjoy your work an

Ready to be a part of a fast-paced, hands-on team?.Do you have the following skills, experience and drive to succeed in this role Find out below.Were on the lookout for a reliable and detail-driven Warehouse Operative to join our clients brand new operations hub in Feltham.If you thrive in a busy en

Apply Today and Become Our Delivery Associate! Full-time self-employed driver positions with us delivering packages and great customer experiences! We are specialists in the contract courier industry and we are looking for self-employed Parcel Delivery Drivers to join our team.Easy and fast a

Qualifications, skills, and all relevant experience needed for this role can be found in the full description below.Hours: 8am -8pm on a rolling rota of 3 shift on 3 shifts off.Choose to live life in Colour by working at Borough Care where we believe that everyone should be encouraged and supported