Principal / Senior Consultant (Non-Clinical)

2 months ago

Hertfordshire UK, Eastern England, United Kingdom Leaman Life Sciences Full time

I am working with my client, who have a superb opportunity for a highly motivated Principal / Senior Consultant (Non-Clinical) to their to join their extremely successful and rapidly growing Regulatory Consultancy


If you are looking to grow your career, playing a key role within the team, developing and mentoring of staff whilst providing high-quality regulatory technical advice and product development strategies for their clients, this could be just the role for you


Key Requirements

  • Providing strategic, technical and regulatory advice/services to clients with a special interest in non-clinical development of human medicinal products.
  • Providing innovative drug development plans, data gap analyses and international regulatory strategies from a non-clinical perspective for complex products within the changing regulatory environment.
  • Establishing and maintaining a high level of technical knowledge within product development and international regulatory affairs.
  • Represent clients in all regulatory agency interactions and provide regulatory solutions to agency objections
  • Contribute to technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Clinical and Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, IMPDs, CSRs, MAAs, NDAs BLAs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications, Protocols, Investigator Brochures, according to area of expertise.
  • Lead multi-jurisdiction programs of work and deliver consulting services within your respective area of expertise.
  • Represent clients in regulatory agency interactions and provide regulatory solutions to agency objections.
  • Lead meetings with stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities.
  • Support the Business Development team in sales/marketing introductions and generate additional business from current clients.
  • Line manage, train, and mentor members of the Operational team, including providing technical leadership.


Skills and Experience

  • A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life science focused MSc or preferably a PhD). Non-clinical (ideally toxicology) educational background is a prerequisite for this position.
  • A minimum of ten years of drug development experience (Principal Consultant) or minimum eight years of experience (Senior Consultant)
  • A minimum of ten years of experience (Principal Consultant) or a minimum of eight years (Senior Consultant) with either FDA, MHRA, and/or EMA, including negotiation. Regulatory experience may include time within a National Competent Authority.
  • Experience with either recombinant proteins (including antibodies), prophylactic and therapeutic vaccines, biosimilar products, advanced therapy medicinal products (tissue, cell and gene therapy) and NCE and/or generic chemical entities.
  • Direct experience preferred in providing strategic regulatory planning from early-stage development up to marketing authorisation, and a proven ability to define and deliver creative scientifically driven solutions to technical development and regulatory issues.
  • Proven ability and willingness to lead a team and deliver education and training in chosen field, both internally, and at scientific conference presentations.


This role requires a minimum of one day a month in the offices in Hertfordshire and a willingness to work flexible hours and travel for short periods, sometimes at short notice, within the country of employment, or internationally.

  • Recruiter/Senior Recruiter

    2 weeks ago

    Hertfordshire, UK, Eastern England, United Kingdom Rachos Recruitment Full time

    We are working with a leading Finance and IT Recruitment Agency based just outside of London (Hertfordshire), who are looking to grow their team and offering, making it the perfect time to get involved!As a Recruiter/Senior Recruiter specialising in the finance & IT sector, you will play a pivotal role in sourcing, attracting, and placing top financial...

  • Senior or Principal Planner

    2 weeks ago

    Cambridgeshire, UK, Eastern England, United Kingdom Bidwells Full time

    Bidwells has an exciting opportunity for a Senior Planner or Principal Planner to join our Cambridge team. This role is ideal for a recently qualified planner who is eager to start an exciting career with a prestigious, forward-thinking, and dynamic team.Our Cambridge team is at the forefront of some of the most significant and transformative projects in the...

  • Senior National Account Manager

    2 weeks ago

    Hertfordshire, UK, Eastern England, United Kingdom Seven Search and Selection Ltd Full time

    Client:Now arguably one of the most innovative food brands in the industry, our client is a household name and aspiring company to work forThey have been at the forefront of innovation and have been responsible for some of the most unique NPD of the food industry in recent yearsThey have won numerous awards and now due to continued growth and progression...

  • Medical Affairs Manager

    3 weeks ago

    Hertfordshire, UK, Eastern England, United Kingdom i-Pharm Consulting Full time

    i-Pharm Consulting are supporting a Global Pharmaceutical group in their search for an experienced Medical Affairs professional for their Ophthalmology therapy area.We are seeking applications from experienced medical affairs professionals with final signatory status for this role, whilst previous experience of Ophthalmology Therapeutic Area would be...

  • Shopper Insight Manager

    5 months ago

    Hertfordshire, UK, Eastern England, United Kingdom Future Work Full time

    Our client is a £multi-million consultancy within the food industry. Their focus is to drive change and to advise retailers and fmcg companies on best practice across a wide range of industry initiatives involving environment, economy and social issues. As part of their expansion programme they are now keen to recruit a Shopper Insight Manager with a...

  • Director of Procurement

    1 month ago

    Hertfordshire, UK, Eastern England, United Kingdom Hyper Recruitment Solutions Full time

    We are currently looking for a Procurement Director - External Manufacturing to join a leading pharmaceutical company based in either London or Hertfordshire. As the Procurement Director - External Manufacturing you will be responsible for shaping and executing procurement strategies for large molecule and vaccine drug substances from an external network....

  • Senior Recruitment Consultant

    2 months ago

    Peterborough, UK, Eastern England, United Kingdom Anne Corder Recruitment Full time

    Location: Peterborough | Reporting to: Head of Recruitment | Salary: Competitive + excellent benefits Are you ready to elevate your recruitment career? At Anne Corder Recruitment, we’re looking for a Senior Recruitment Specialist to join our innovative team. This is your chance to make a real impact by leading recruitment campaigns across a diverse client...

  • Application Specific Integrated Circuit Design Engineer

    3 weeks ago

    Cambridgeshire, UK, Eastern England, United Kingdom IC Resources Full time

    Senior or Principal ASIC Design EngineerCambridge This is an exciting opportunity for a Senior or Principal ASIC Design Engineer to join a talented and well established HW team in the beautiful City of Cambridge. You will join a company who have a passion for creativity and innovation, with over millions of their product sold in the last decade this is a...

  • Head of Risk

    7 days ago

    Hertfordshire, UK, Eastern England, United Kingdom Compliance Professionals Full time

    THE COMPANY: Our client is a boutique financial services firm based in St Albans, seeking a Head of Risk and Compliance on a permanent basis. This is a great opportunity for someone to work locally in a close-knit team.THE RESPONSIBILITIES:Ensure that the companies have the correct level of FCA regulatory oversight and that the procedures and monitoring...

  • Risk and Business Continuity Manager

    3 weeks ago

    Hertfordshire, UK, Eastern England, United Kingdom Audit & Risk Recruitment Full time

    Audit & Risk Recruitment have been engaged by an international healthcare business who, following a period of rapid growth through acquisition, needs to recruit a Risk and Business Continuity Manager to review their existing business continuity processes, policies and systems before designing and implementing a fit for purpose business continuity...

  • Senior Research Scientist

    2 weeks ago

    Cambridgeshire, UK, Eastern England, United Kingdom Hyper Recruitment Solutions Full time

    We have an exciting opportunity for a Senior Research Scientist - Microbiology to join a leading biopharmaceutical company based in the Cambridgeshire area. As the Senior Research Scientist - Microbiology, you will be joining the pre-clinical development team and be responsible for contributing to the advancement of cutting-edge microbiology-based...

  • Principal Consultant- H&S Principal Designer

    2 weeks ago

    Bristol, UK, South West England, United Kingdom iO Associates - UKEU Full time

    Are you an experienced Health & Safety Consultant with a passion for excellence and innovation? Our client is seeking a Principal Consultant - H&S Principal Designer to join their team in Bristol. This is a unique opportunity to work on ambitious, highly technical projects within a global consultancy that values its people and their development.As a...

  • Healthcare Assistant

    4 days ago

    Essex, UK, Eastern England, United Kingdom Stonor Medical Full time

    Role: Hospital Healthcare Assistant (Wards/Outpatients) x 2Location: EssexSalary: £23,000Permanent/ full-time.Start date: ASAPMust not require sponsorship as hospital cannot offer this.A fantastic private hospital based in Essex is looking for an experienced Hospital Healthcare Assistant to join their growing team.HCA Duties:To provide support to the...

  • Company Secretary

    1 month ago

    Hertfordshire, UK, Eastern England, United Kingdom Fame Recruitment Full time

    A leading accountancy practice located in Hertfordshire are recruiting for a Company Secretarial Manager to join their team.Reporting to the Partners, this position will play a key role in maintaining the efficiency of the secretarial team, collaborating with other departments and managing client relations.This position offers hybrid working, flexi hours,...

  • Application Specific Integrated Circuit Design Engineer

    6 days ago

    Cambridgeshire, UK, Eastern England, United Kingdom IC Resources Full time

    Principal ASIC Design EngineerCambridgeThis is an exciting opportunity for a Senior or Principal ASIC Design Engineer to join a talented and well established HW team in the beautiful City of Cambridge. You will join a well known industry name who have a passion for creativity and innovation, with over millions of their product sold in the last decade this is...

  • Senior Embedded Firmware Engineer

    3 days ago

    Cambridgeshire, UK, Eastern England, United Kingdom IC Resources Full time

    Senior Embedded Firmware EngineerI am working with a successful, growing consultancy who specialise in innovation, design and development. They work with a range of industries and have a reputation for finding creative solutions to technical problems.They are looking for a Senior Embedded Firmware Engineer to join their growing team.The Role:The Senior...

  • Biomedical Scientist Team Manager- Microbiology

    7 days ago

    Essex, UK, Eastern England, United Kingdom SYNLAB UK & Ireland Part time

    We are currently recruiting for Biomedical Scientist Band 7 Team Manager to join our fast paced and dynamic Microbiology team. This role is part of a team which provides an efficient and effective Microbiology service to two general hospitals (Southend University/Basildon and Thurrock University Hospital Trusts) and local GP community. We are willing to...

  • IT Resilience Consultant

    4 weeks ago

    Essex, UK, Eastern England, United Kingdom Barclay Simpson Full time

    Role Overview:IT Resilience Consultant (second line function) required for a global bank. You will be responsible for leading the strategic development and harmonization of a comprehensive resilience framework across multiple jurisdictions. In this role, you will collaborate closely with senior management to define and shape the operational resilience...

  • Senior Electrical Engineer

    2 weeks ago

    Peterborough, UK, Eastern England, United Kingdom Global Engineering Talent Full time

    Job Title: Senior Electrical Engineer (Building Services)Location: PeterboroughSalary: Up to £75,000 or £50 per hour (LTD)Start Date: ASAPAre you an experienced Electrical Engineer with a background in Building Services? Join a dynamic and growing building services consultancy that delivers a wide range of projects, from commercial and high-end residential...

  • Employment Solicitor

    5 months ago

    England, Hertfordshire, Hertfordshire, Eastern England, United Kingdom Austen Lloyd Limited Full time

    EMPLOYMENT SOLICITOR / LEGAL EXECUTIVE - LEGAL 500 FIRM - HERTFORDSHIRE Employment Solicitor / Legal Executive (4 years +) A rare opportunity with great potential for a Solicitor / Legal Executive with a solid grounding in Employment matters at a substantial national firm We are looking for an Employment Solicitor looking to take a step up in their...