Principal Consultant

3 weeks ago

Sheffield, Sheffield, United Kingdom Scendea Full time

The Role

Scendea is seeking a highly motivated individual to join our global team as a full-time Principal Consultant (CMC). This is a hybrid position, affiliated to either of our UK, Netherlands, US, or Australia offices, with a requirement to work in the office a minimum of one day per month.

This is an excellent opportunity to progress your career at a rapidly growing Regulatory Consultancy. You will have the opportunity to play a key role in the development and mentoring of staff whilst providing high-quality regulatory technical advice and product development strategies for clients.

Role Requirements

  • Provide strategic, technical and regulatory advice/services to clients with a special interest in CMC development of human medicinal products.
  • Provide innovative drug development plans, data gap analyses and international regulatory strategies from a CMC perspective for complex products within the changing regulatory environment.
  • Contribute to technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Paediatric plans/applications, Investigator Brochures, IMPDs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, DMFs 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.
  • Ensure delivery of project goals within agreed timelines, maintaining oversight of project budgets.
  • Lead meetings with internal and external stakeholders on matters related to any current and/or future projects, contracts, or new business opportunities.
  • Support Scendea's Business Development in sales/marketing introductions and generate additional business from current clients.
  • Line manage, train, and mentor members of the Scendea Operational team, including providing technical leadership.

Skills and Experience

  • A high scientific calibre with a relevant science focused BSc (or equivalent), and a higher degree in a biomedical field or equivalent (e.g., a life/physical science focused MSc or preferably a PhD).
  • Extensive experience in CMC strategy and a minimum of ten years of experience in CMC development and regulatory compliance.
  • Expertise in CMC-related regulatory requirements, including FDA, EMA, ICH guidelines
  • A minimum of ten years of regulatory experience, working with either FDA, and/or MHRA/EMA/TGA submissions, including meetings/negotiation. Regulatory experience may include time within a National Competent Authority.
  • Experience with a broad range of products would be beneficial, including recombinant proteins and peptides (including antibodies), prophylactic and therapeutic vaccines, biosimilar products, advanced therapy medicinal products (tissue, cell and gene therapy), RNA or DNA based products, and live biotherapeutics.
  • 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.
  • Experience in consultancy and/or an outgoing personality that supports the ability to showcase their expertise and the business to new potential clients.
  • Proven ability and willingness to lead a team and deliver education and training in chosen field, both internally, and at scientific conference presentations.
  • Exemplary organisational and time management skills with a high level of attention to detail, and the proven ability to work both proactively and autonomously.
  • High level of verbal communication and presentation skills in English, computer literacy, and competency in MS Office programs.
  • Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the country of employment, or internationally.

Benefits

  • A competitive salary.
  • Generous bonus program, which rewards success.
  • 26 days' vacation plus discretionary additional days for birthday and work anniversary and public holidays.
  • Employer pension contribution
  • Provision/Contribution of Private Healthcare insurance
  • Access to Employee Assistance Programme.
  • Employee Ownership Trust Scheme.
  • A challenging and stimulating position for a dynamic and competent scientist, looking to contribute to a growing business and a rapidly expanding team.
  • Coaching, mentoring and support of your continuous learning, and professional development within a highly recognised international team.

The Company

Scendea is an international product development and regulatory consulting group delivering market-leading scientific expertise & regulatory solutions, to advance healthcare innovation worldwide. We are passionate about delivering strategic and operational support to clients, with a strong commitment to problem-solving and redefining customer service. Our goal is to streamline the product development process, reduce time-to-market, and minimise overall development costs.

With a current team of over 50 staff based in the UK, Netherlands, Australia, and the US, Scendea is undergoing a period of significant growth, with the addition of new office locations and service lines to facilitate the delivery of expert and strategic global regulatory consulting services to our rapidly growing client base. We are equally committed to making a positive impact on society by managing our environmental impacts and contributing to a low-carbon economy. Our inclusive work culture values transparency, ethical collaboration with clients, and employee involvement in key decision-making processes, ensuring that our team is respected, supported, and engaged.

As a Scendea Employee

Part of what makes Scendea successful is the highly motivated people who work for us and their enthusiasm for what we do and stand for. We recruit individuals whose passion, drive, integrity and customer orientation shines through. You are a motivated individual who can instil trust and confidence in our customer relationships whilst having a natural aptitude for getting the best out of people internally. You will inspire others through your commitment, motivation, expertise, professional manner and always placing the customer at the centre of everything you do.

Eligibility & Conditions

Applicants must reside and be eligible to work in either the UK/Netherlands/US/Australia without the requirement for sponsorship now or in the future. Closing date for applications is Tuesday 22nd April and candidates will be notified of the outcome of their application by no later than Friday 2nd May 2025.

  • Senior/Principal Environmental Consultant

    2 weeks ago

    Sheffield, Sheffield, United Kingdom CleanTech Talent Full time

    Senior or Principal Environmental Consultant Environmental Impact Assessment (EIA) Location: UK Wide (with flexible hybrid working & remote for the right person) Sheffield, Manchester, Basingstoke, Exeter, Scotland, Bristol Salary: Senior £35,000 - £45,000Principal - £45,000 - £55,000 negotiable Coordinate and manage EIA in a range of sectors such...

  • Senior Principal Consultant

    2 weeks ago

    Sheffield, Sheffield, United Kingdom Genpact Full time

    Senior Principal Consultant - Technology Risk & Control Specialist4 days ago Be among the first 25 applicantsGenpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value...

  • Senior Principal Designer

    2 weeks ago

    Sheffield, Sheffield, United Kingdom Brandon James Full time

    A leading multi-disciplinary consultancy is seeking an experienced CDM Principal Designer to join their dynamic team in Sheffield. The successful CDM Principal Designer will play a crucial role in ensuring the safety and compliance of a diverse range of construction projects. This position offers an exciting opportunity to work in a collaborative...

  • Senior/Principal Ecologist

    2 weeks ago

    Sheffield, Sheffield, United Kingdom Access Talent Group Full time

    Access have partnered with a multi-disciplinary consultancy with large scale projects in the UK. After continued success and increasing demand, our client is searching for a Senior or Principal Ecologist to be based out of their Sheffield office who is motivated, ambitious and passionate about delivering excellent projects. Our client has established...

  • Principal/Associate Environmental Consultant

    3 days ago

    Sheffield, Sheffield, United Kingdom Lucion Environmental Advisory Full time

    Principal / Associate Environmental Consultant - Environmental Due DiligenceLocation: Hybrid - 2/3 days per week in our offices in either London, Manchester or LeedsPermanent, full-time contractWho Are We?Lucion is a purpose-driven, beyond net-zero company, dedicated to protecting people from hazardous environments and protecting the environment from the...

  • Principal/Associate Environmental Consultant

    1 week ago

    Sheffield, Sheffield, United Kingdom Lucion Environmental Advisory Full time

    Principal / Associate Environmental Consultant - Environmental Due DiligenceLocation: Hybrid - 2/3 days per week in our offices in either London, Manchester or LeedsPermanent, full-time contractWho Are We?Lucion is a purpose-driven, beyond net-zero company, dedicated to protecting people from hazardous environments and protecting the environment from the...

  • Principal Geo-Environmental Engineer

    1 week ago

    Sheffield, Sheffield, United Kingdom Calibre Search Full time

    Position: Principal Geo-Environmental EngineerLocation: SheffieldSalary: 45-55kI am working with one of the largest independent engineering consultancies in the North of England, looking to add a principal geo-environmental engineer with a proven track record within the industry, to their Sheffield office. The ground engineering team has been highly...

  • Principal Geo-Environmental Engineer

    2 weeks ago

    Sheffield, Sheffield, United Kingdom Calibre Search Full time

    Position: Principal Geo-Environmental EngineerLocation: SheffieldSalary: £45-55kI am working with one of the largest independent engineering consultancies in the North of England, looking to add a Principal Geo-Environmental Engineer with a proven track record within the industry to their Sheffield office. The ground engineering team has been highly...

  • Principal Geo-Environmental Engineer

    2 weeks ago

    Sheffield, Sheffield, United Kingdom Calibre Search Ltd Full time

    Position: Principle Geo-Environmental EngineerLocation: SheffieldSalary: £45-55kI am working with one of the largest independent engineering consultancies in the North of England, looking to add a principal geo-environmental engineer with a proven track record within the industry, to their Sheffield office. The ground engineering team has been highly...

  • CDM Consultant

    2 weeks ago

    Sheffield, Sheffield, United Kingdom Mott MacDonald Full time

    Contract Type: PermanentWork Pattern: Full TimeMarket: WaterJob Ref: 5953Position location: London, UK / Reading, UK / Birmingham, UK / Manchester, UK / Liverpool, UK / Leeds, UK / Bristol, UKRecruiter contact: Alice RoostanWe're a global engineering, management, and development consultancy.Our purpose is to improve society by considering social outcomes in...

  • Principal Civil/ Infrastructure Engineer

    5 days ago

    Sheffield, Sheffield, United Kingdom ATTB - The Big Jobsite Full time

    Job DescriptionPrincipal Civil Engineer – InfrastructureJob Type: Full-timeSalary: £60,000 - £65,000We are working with a consultancy who are seeking a Principal Civil Engineer for their highly regarded Infrastructure Team. The successful candidate will work on a range of projects spanning commercial, Education, Healthcare, Housing, Industrial, Leisure...

  • Principal Civil/ Infrastructure Engineer

    1 week ago

    Sheffield, Sheffield, United Kingdom ATTB - The Big Jobsite Full time

    Job DescriptionPrincipal Civil Engineer – InfrastructureJob Type: Full-timeSalary: £60,000 - £65,000We are working with a consultancy who are seeking a Principal Civil Engineer for their highly regarded Infrastructure Team. The successful candidate will work on a range of projects spanning commercial, Education, Healthcare, Housing, Industrial, Leisure...

  • Principal Geo-Environmental Engineer

    3 days ago

    Sheffield, Sheffield, United Kingdom Calibre Search Full time

    Position: Principle Geo-Environmental EngineerLocation: SheffieldSalary: £45-55kI am working with one of the largest independent engineering consultancies in the North of England, looking to add a principal geo-environmental engineer with a proven track record within the industry, to their Sheffield office. The ground engineering team has been highly...

  • Principal Geo-Environmental Engineer

    1 week ago

    Sheffield, Sheffield, United Kingdom ATTB - The Big Jobsite Full time

    Position: Principle Geo-Environmental EngineerLocation: SheffieldSalary: £45-55kI am working with one of the largest independent engineering consultancies in the North of England, looking to add a principal geo-environmental engineer with a proven track record within the industry, to their Sheffield office. The ground engineering team has been highly...

  • Principal Drainage Engineer

    2 hours ago

    Sheffield, Sheffield, United Kingdom ameygroupi Full time

    Amey are a leading provider of full life-cycle engineering, operations and decarbonisation solutions, for transport infrastructure and complex facilities.Working for us, you'll be delivering sustainable infrastructure solutions that enhance life and protect our shared future.Our people are driven by a set of strong values, based on safety, insight and...

  • Principal Drainage Engineer

    5 days ago

    Sheffield, Sheffield, United Kingdom ENGINEERINGUK Full time

    You will need to login before you can apply for a job.Sector: EngineeringRole: ProfessionalContract Type: PermanentHours: Full TimeAmey are a leading provider of full life-cycle engineering, operations and decarbonisation solutions for transport infrastructure and complex facilities.Working for us, you'll be delivering sustainable infrastructure solutions...

  • Principal Drainage Engineer

    6 days ago

    Sheffield, Sheffield, United Kingdom ENGINEERINGUK Full time

    You will need to login before you can apply for a job.Sector: EngineeringRole: ProfessionalContract Type: PermanentHours: Full TimeAmey are a leading provider of full life-cycle engineering, operations and decarbonisation solutions for transport infrastructure and complex facilities.Working for us, you'll be delivering sustainable infrastructure solutions...

  • Principal Wastewater Modeller

    7 days ago

    Sheffield, Sheffield, United Kingdom Calibre Search Full time

    Principal Wastewater Modeller Leeds Are you a Wastewater Modeller looking for a new challenge? Would you like the opportunity to work on some non-conventional modelling schemes? If you are looking for a new challenge and a varied workload away from the norm this could be the role for you. Our client are a leading design, engineering, environment and...

  • Principal PBPK Consultant

    1 week ago

    Sheffield, Sheffield, United Kingdom Certara Full time

    Overview About Certara Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries Certara accelerates medicines using...

  • Consultant Ecologist

    7 days ago

    Sheffield, Sheffield, United Kingdom Navartis Full time

    Job Description Consultant Ecologist Location: Sheffield Salary: £24,000 - £36,0000 dependant on experience plus package Summary A leading UK environmental group providing consultancy, services and solutions to help take care of the Earth is looking for Consultant Ecologists to join in delivering a vast range of multi-disciplinary...