Latest Vacancies

Job TitleSectorAreaSalary Package Details
Global Regulatory Manager - ContractCentral LondonWe are currently partnering with a Global pharma company who are looking for a Global Regulatory Pharma / Biotech ApplyRegulatory Affairs Manager – Medical DevicesNorth LondonRegulatory Affairs Manager – Medical Devices Location: Hertfordshir Medical Devices ApplyRegulatory Affairs Manager – MedicinesNorth LondonRegulatory Affairs Manager – Medicines Location: Hertfordshire (op Pharma / Biotech ApplyRegulatory Affairs Manager – Medical Devices – Hourly Rate ContrNorth LondonRegulatory Affairs Manager – Medical Devices – Hourly Rate Contractor Medical Devices Apply

About us

Linkfield Life Sciences Ltd are a Regulatory Affairs Recruitment Partner, working with organisations and professionals throughout the Life Sciences sector, we are a family run business purely focused on Regulatory Affairs. Our founder and chief Regulatory recruiter, Natalie Hopkins has specialised in this industry her entire career, allowing her to build a wealth of technical knowledge within the Regulatory field, as well as an extensive Regulatory network. It is on this knowledge combined with strong core values that Linkfield Life Sciences has been built. Established in early 2016, we are already partnered with some major players in the industry and the fact that you are here shows we are ever expanding.

 

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Global Regulatory Manager - Contract

£ 60 ~ 70 Hourly Rate
We are currently partnering with a Global pharma company who are looking for a Global Regulatory Manager to work on a mixture of Emerging Markets and EU Post Marketing activities. The selected professional will be a confident leader who is comfortable working on a variety of products and projects. Experiences with divestment and MAH transfers will be a bonus. This is a 1 years daily rate contract based in London 3 days per week with the flexibility to work from home. If more home working is needed this can be negotiated for the right experience level. For further information please get in touch with Natalie Jones 0207 183 5059 natalie@linkfieldgroup.com
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Regulatory Affairs Manager – Medicines

£ 0 ~ 0 Competitive
Regulatory Affairs Manager – Medicines Location: Hertfordshire (option for 1 day home working)Salary: Competitive Annual Salary + 25 days holiday, Life Assurance, leave early on a Friday, Pension Scheme, Buy and Sell Annual leave, Non-Contractual Annual Bonus We are currently working with a growing Regulatory Affairs team who are looking for a strong Regulatory Affairs Manager. We are looking for a professional with the following: ·        Experience managing regulatory affairs projects.·        Interpreting scientific data, including scientific writing of both CMC and clinical documents (e.g. authoring Quality Overall Summaries, Clinical Overviews, paediatric plans, orphan drug applications).·        Experience defining EU regulatory strategy for new drugs and line extensions along with EU procedural experience, e.g. CP or DCPFor further information please get in touch with Natalie Jones on 0207 183 5059 or email natalie@linkfieldgroup.com
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Regulatory Affairs Manager – Medical Devices – Hourly Rate Contr

£ 0 ~ 0 Hourly Rate
Regulatory Affairs Manager – Medical Devices – Hourly Rate Contractor Location: Hertfordshire (option for 2 days home working if desired)Salary: Competitive Hourly Rate We are currently working with a growing Regulatory Affairs consultancy who are looking for a strong Regulatory Medical Devices consultant to support a few key projects. Ideally, we are looking for a professional with the following: •                    MDR requirements experience •                    Proficient with technical files in class I and II (any experience with class III would be a bonus)•                    Experience with writing documents e.g. clinical evaluation reports, risk management and design documents•                    Knowledgeable on ISO13485•                    There may also be a demand for some support on the medicines side. Training will be provided in this instance if needed•                    To use scientific knowledge and creativity to devise regulatory strategiesFor further information please get in touch with Natalie Jones on 0207 183 5059 or email natalie@linkfieldgroup.com
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Regulatory Affairs Manager – Medical Devices

£ 0 ~ 0 Hourly Rate
Regulatory Affairs Manager – Medical Devices Location: Hertfordshire (option for 1 day home working if desired)Salary: Competitive Annual Salary +  25 days holiday, Life Assurance, Leave early on a Friday, Pension Scheme, Buy and Sell Annual leave, Non Contractual Annual Bonus We are currently working with a growing Regulatory Affairs consultancy who are looking for a strong Regulatory Medical Devices Manager. We are looking for a professional with the following: •                    MDR requirements experience •                    Proficient with technical files in class I and II (any experience with class III would be a bonus)•                    Experience with writing documents e.g. clinical evaluation reports, risk management and design documents•                    Knowledgeable on ISO13485•                    There may also be a demand for some support on the medicines side. Training will be provided in this instance if needed•                    To use scientific knowledge and creativity to devise regulatory strategiesFor further information please get in touch with Natalie Jones on 0207 183 5059 or email natalie@linkfieldgroup.com
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Senior Regulatory Affairs Officer

£ 40,000 ~ 45,000 Competitive
This a new position in a growing Regulatory team with one of our key partners. The role:Obtaining new and maintaining existing Marketing AuthorisationsMaintaining regulatory activities related to one or more new drug applicationsMaintaining drug licences for designated products in a designated territoriesProposing and participating in Regulatory strategy decisions for new Marketing Authorisations in a designated territoriesManaging documentation for applications to relevant authorities and managing the regulatory submission process to approval, product launch and beyondMaintaining information tools, documentation and procedures to ensure regulatory compliance of company products released to marketMaintaining Regulatory Affairs data bases (RIM/ IDMP), documentation and procedures to ensure regulatory compliance of company products released to market.For further information please get in touch with Natalie Jones on 0207 183 5059 or at natalie@linkfieldgroup.com
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Vice President of Regulatory Affairs - Biotech

£ 0 ~ 0 Competitive
This is a new appointment for a Vice President of Regulatory Affairs working for an inspiring company who are at the forefront of developing life-changing Gene Therapies. With three Gene Therapy products and an exciting pipeline, we are seeking a seasoned professional with a passion for Gene Therapy and making a real difference to patients lives. Choice of three Locations: Hertfordshire, UK / Boston, US / New York, US (Flexibility for a combination of office and home-based working)The appointed candidate will be accountable for all aspects of Regulatory Affairs in all territories in which the company operates. This includes clinical, CMC and Regulatory Operations. As the company grows the Vice President of Regulatory Affairs will be responsible for building an effective Regulatory Affairs function that continues to meet the needs of the company.Responsibilities include: ·        For each product in development the creation, agreement and delivery of a global Regulatory strategy, that is consistent with business objectives.·        Ensuring preparation of high-quality Regulatory documents including, but not limited to, IMPD/CTA/IND, briefing documents, orphan drug applications, paediatric investigational plans, MAA/BLA and other Regulatory filings·        Proactively identifying risks to the Regulatory plans and developing ways to mitigate risks·        Taking responsibility for training of staff in Regulatory matters as required ·        Leading and managing Regulatory authority interactions·        Provide strategic direction and operational Regulatory support to the project teams and other groups within company as required·        Keep abreast of relevant Regulatory intelligence and ensuring this is communicated, appropriately, across the company.·        Managing third party providers such as Regulatory service providers and medical writers to ensure business objectives are met·        Remain up to date on global Regulatory requirements including clinical and CMC aspects.Education and Previous Regulatory Experience Requirements:·        Bachelor degree in Life Science - Master or PhD preferred·        Significant experience in Regulatory Affairs including experience of European and US Regulatory environments from early development, through CTA/IND, to filing of MAA/BLA and maintenance of approvals. ·        Japanese Regulatory Affairs experience would be beneficial.·        Experience of the development of GTMP (Gene Therapy Medicinal Products) and rare disease products with a strong working knowledge of the Regulatory requirements including knowledge of accelerated and conditional approval routes within FDA and EMA.·        A proven ability to create and drive an effective clinical Regulatory strategy.·        Experience of planning and leading meetings with the FDA, the EMA and European national Regulatory authoritiesTo book a confidential discussion regarding this appointment please email Natalie directly with your details to arrange a call Natalie@linkfieldgroup.com
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Senior Publisher - Contract

£ 400 ~ 500 Competitive
We have an urgent Senior Regulatory Publishing contract position available with a Global Pharmaceutical company ---------------------------------------Job Title: Regulatory Senior Publisher – Hands on eCTD Publishing experience is required. This position will cover EU and International markets for two key Oncology products.   Daily Rate: Lucrative daily rate negotiable  Location: London based with home-working for 2-3 days per week as needed  Contract length: Until January 2020 Start Dates: As soon as possible  ---------------------------------------For further information please contact Natalie Jones on 0207 183 5059 on email natalie@linkfieldgroup.com
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Regulatory Affairs Manager - Food Supplements

£ 0 ~ 0 Competitive
We are currently partnering with an exciting SME who are going through a period of growth and expansion. As the first Regulatory Affairs professional in the business you will work closely with the Technical Manager as well as the founder of the company in developing regulatory strategies that enable corporate growth and profitability. You will also be responsible for the following activities;Fast growing manufacturer and distributor of global blue chip brandsLocation: Kent, UKReview of labelling and marketing material for compliance with global regulatory requirements, including usage of claims relating to nutritional content, structure and function and other marketing claims.Food labelling and dietary supplement expertise collaborating with New Product Development, Marketing, Sales, Quality Assurance, Purchasing, and others to leverage regulations.Provide regulatory guidance and answers compliance-related questions regarding new and reformulated product concepts.Identifies and provides resolution to strategic and tactical regulatory issues pertaining to food labelling. Liaise as necessary with global regulatory authorities and internal distribution partners to ensure efficient registration of products.Assist the Technical Manager in the maintenance of the company quality management system.For further information please get in touch with Natalie Jones via natalie@linkfieldgroup.com or call 0207 183 5059
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Regulatory Affairs CMC Manager - Biologics

£ 60,000 ~ 70,000 Annual Rate
I am currently partnering with a ground breaking clinical stage biotechnology company who are looking to expand their talented team by hiring a Regulatory CMC Manager to work alongside their CMC Director. With a growing clinical portfolio, early phase Regulatory CMC experience is needed for this position. Ideally the successful candidate will have a biotech or biologics background and experience working with rare disease products, although this is notessential. This is an excellent opportunity to join an outstanding organisation going through a period of growth and development and plays a pivotal role in developing life changing medicines. Responsibilities: ·      To work closely with other regulatory sub-teams to develop CMC regulatory strategy, prepare CMC regulatory documents, contribute in regulatory meetings and ensure ongoing compliance.·      Provide regulatory input to help shape CMC regulatory strategy, identifying potential regulatory challenges and tools for optimising the time/cost/risk profile.·      Preparation of CMC regulatory documents including managing writing/reviewing timelines and compiling finished documents·      To work on responses to CMC regulatory questions, CMC scientific advice briefing documents, CMC Module 2 and 3 documents, PIP/PSP, PRIME, Breakthrough/RMAT, etc.·      To co-ordinate company preparations for CMC meetings with regulatory agenciesExperience Required: ·      Strong scientific background ·      Educated to at least degree level preferably in a biological science or pharmacy·      Technical and/or regulatory experience of biologics·      Experience of regulatory strategies for rare disease and/or novel platform development is desirableThis position may require a small amount of travel to meetings in Europe, US or further afield as the role requires.For further information on this position please get in contract with Natalie Jones on 0207 183 5059 or email Natalie directly at natalie@linkfieldgroup.com
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Senior Regulatory Affairs Manager - Clinical Stage Biotech

£ 65,000 ~ 70,000 Annual Rate
We are currently partnering with an exciting clinical-stage Biotechnology company looking to hire a Senior Regulatory Manager to work alongside the Regulatory Affairs Senior Director. This is a truly ground breaking company with a patient centric approach. The successful candidate will participate in the development and implementation of regulatory strategy for specific programmes. Office Location: Hertfordshire with the flexibility for 2 – 3 days a week working from home if desired. Responsibilities:·       To design the execution of certain regulatory activities/submissions necessary to support global product development and registration ·       Support regulatory sub-team and product development teams in all aspects of regulatory affairs, both strategic and operational ·       Ensuring preparation of high-quality regulatory documents including, but not limited to, IMPD/CTA/IND, scientific advice briefing documents, orphan drug applications, PIPs/PSPs, MAA/BLA, responses to questions and other regulatory filings to support regulatory compliance. ·       Act as contact point for internal and external clients, including CROs and regulatory authorities ·       Help with training of staff in regulatory matters. ·       Extensive project management activities across Regulatory Affairs Education / Requirements: ·       Relevant degree in a life science / science discipline. ·       Previous Regulatory Affairs experience working on early phase products ·       Rare disease / Orphan Drug applications experience is preferred but not essential For further information on this position please get in contract with Natalie Jones on 0207 183 5059 or email Natalie directly at natalie@linkfieldgroup.com
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Global Head of Quality Assurance

£ 100,000 ~ 120,000 Annual Rate
Linkfield Life Sciences are currently partnering with a small organisation in a phase of rapid growth. Due to rapid expansion of the company’s global supply chain has resulted in a need for a Global Head of Quality Assurance. This position reports to the COO and covers all Quality Assurance activities as well as some Regulatory Affairs duties globally. This position will be part of the Senior Leadership Team and therefore represents a critical hire for the Company. Through strong interaction at a senior management level, this is an ideal role for a candidate seeking a robust development opportunity in the life sciences industry.Role Responsibilities & Candidate Requirements: ·        Oversee and manage QA & RA employees at three sites in the US, UK and Switzerland ensuring proper and efficient execution of the company’s QMS ·        Define QA resourcing needs and drive recruitment of new staff as appropriate·        Ensure QA are integrated into all leadership discussions, Company projects and business activities·        Extensive work experience covering cGDP and GDP at European or Global level; previous experience as an RP, with GMP, MIA/IMP licenses and/or a QP certificate would be a plus·        Experience conducting audits of subcontractors and managing audits from third parties, including regulatory authorities·        High attention to detail and a high standard for quality work products·        Solutions-oriented leader with track record of finding creative solutions to solving problems·        Strong decision maker and comfort with making decisions balancing multiple points of view and factoring in associated risks·        International travel estimated at up to 20%Compensation and Benefits:•                    Salary – reflective of experience (up to £120,000 circa)•                    Attractive performance incentive plan with profit sharing•                    Car allowance•                    Company pension plan with company match•                    Vacation and paid sick leaveIf you are interested in discussing the full details, please get in touch with Natalie Jones on +44 (0)2071835059 or email her directly on natalie@linkfieldgroup.com
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Regulatory Affairs Senior Associate / Associate Manager - CTA

£ 40,000 ~ 52,000 Annual Rate
Based at a growing organisation, working on a wide scope of products and therapy areas, this key partner of ours is looking for a Regulatory professional with strong CTA experience. Responsibilities:Prepare and submit Clinical Trial Authorisation (CTA) applications and substantial amendments to competent authorities throughout Europe.Assist with managing workload of clinical trial team and prioritisation decisions.Review and extract information from clinical trial associated documentation (incl. IMPDs, IBs, EudraCT, Protocols & labelling)Quality control check junior member of staff work and contribute to their training. ExperienceGraduate in relevant scientific discipline Broad Regulatory CTA experience covering a range of EU countries Experience in preparing submissions for both competent authority and ethics committees.Experience with IRAS system and HRA process for UK submissions. Ability to work under pressure and achieve timely submission and regulatory approvalsGood computer skillSelf-motivated with excellent communication skillsStrong attention to detailReports to: Regulatory Affairs Senior ManagerFor further information contact Natalie Hopkins on 0207 183 5059 or email natalie@linkfieldgroup.com
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Regulatory Affairs Consultant - Brexit Project

£ 70 ~ 75 Hourly Rate
This is a new Regulatory Consultant role driven from Brexit.  We are currently partnering with a Medium Sized Pharmaceutical company to secure a seasoned consultant for an initial 6 month project with a possibility of extension. The work will be focused on; ·        Managing licencing changes (e.g. Market Authorisation Holder (MAH), labeling changes, artwork changes, testing site changes &multiple market packs etc).·        Covering EU markets.·        Extensive experience with project management will be required·        Ownership of the Regulatory strategy around all Brexit activities across Europe.Rate: Negotiable Contract Length: Initial 6 months Location: Slough Start date: ASAPFor more information please contact Natalie Hopkins on 0207 183 5059
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Regulatory Affairs Manager

£ 58,000 ~ 65,000 Annual Rate
 We are currently partnering with a exciting organisation who are looking to expand their Regulatory Affairs Management Team. Working largely on Post Marketing / Post Approval and CMC activities this position will be a key Project Lead. There is also the opportunity to line management more junior Regulatory staff if desired. General Responsibilities:Management of Regulatory project work/project lead Preparation and coordination or review of documentation or dossiersRegulatory strategy (pre-submission or post-approval stages)Maintaining an awareness of the EU Regulatory landscape and changing regulatory requirementsKey Responsibilities:Preparation and project management of Marketing Authorisation Applications (MAA)Authoring of CMC documents and/or complete Module 3sCoordination of preparation of m2, m4 and m5 for MAAsPreparation and review of responses to questionsPreparation and review of post-approval submissionsDossier reviews and gap analyses Assisting with Scientific Advice procedures Professional Experience:2:1 (or above) graduate in a relevant scientific disciplineBroad & deep regulatory affairs experienceStrong understanding of the EU regulatory environment including guidelinesAbility to work under pressure and achieve timely submission and regulatory approvalsAbility to analyse issues and propose solutionsTo apply please send your CV through to natalie@linkfieldgroup.com
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Regulatory Affairs/ QA Technical Director

£ 80,000 ~ 110,000 Annual Rate
This is a brand-new position reporting into the VP of the department, based at the UK/Ireland affiliate of a Global Pharmaceutical company based in South London.As the Technical Director, you will have two QA line reports and four Regulatory Affairs line reports as well as being responsible for any technical contractors. You will oversee both functions and be in charge of the strategy as well as getting involved in some complex hands on technical work. With this being a new role, you will have the opportunity to shape and develop the department. 
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Regulatory Affairs Senior Manager - EU

£ 65,000 ~ 75,000 Annual Rate
A cutting-edge biotech working on products to treat cancer using cellular immunotherapy. With three products in phase I and II and a further five products in pre-clinical stages, they looking for a Regulatory Affairs Senior Manager with strong drug development experience. ResponsibilitiesPrepare and submit clinical trial applications, substantial amendments, regulatory responses, orphan drug designation requests and maintenance, PIPs, and MAAs to meet company goals and timelines. Must be able to write significant sections of regulatory submissions with input from internal teams and consultants. Schedule, prepare meeting packages for, and coordinate scientific advice meetings with regulatory authorities.Represent regulatory affairs function within cross-functional product development teams. Act as a company expert in EU Regulatory Affairs, providing updates, support and education as required.Act as primary contact to EU regulatory authorities.Review all regulatory agency compliance materials to guarantee accuracy, timeliness, comprehensiveness, and adherence to regulatory standards.Maintain current knowledge of relevant EU regulations including proposed and final rules and communicate changes to internal team.Liaise with external collaborators and manage external resources e.g. CROs, consultantsContribute to the global regulatory function and organisation of company regulatory data (SOPs, trackers, templates, etc).Play an instrumental role in the global regulatory affairs function through active participation and collaborationInvolved with development of regulatory strategies for new products.Provide regulatory input on other company activities such as pharmacovigilance, medical affairs, risk management, company brochures, and due diligence.For further information please contact Natalie Hopkins on 0207 183 5059 or email natalie@linkfieldgroup.com
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To find out more about Linkfield Life Sciences Ltd, and how we can partner with you to support your Regulatory Affairs recruitment requirements, please contact us below:

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Office 2b
Mercury House,
High Street,
Tattenhall, TN8 6EN

  • 0207 183 5059
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