Regulatory Affairs Specialists
1 day ago
Are you looking to advance your career in regulatory affairs?
At Scendea, we deliver market-leading scientific expertise and regulatory solutions to advance healthcare innovation worldwide. We are dedicated to streamlining medicinal product development, reducing time-to-market, and minimising costs for our biotech and pharmaceutical clients. If you are experienced in regulatory affairs and passionate about providing strategic and technical solutions to complex product development challenges, we’d love to hear from you.
What’s involved?
You will play a critical role in providing regulatory guidance and innovative strategies across a wide range of medicinal product development activities. This includes:
- Providing innovative drug development plans, data gap analyses and international regulatory strategies for complex products within the changing regulatory environment.
- Contributing to technical authorship and review of development regulatory documents including Regulatory Strategy Plans, Clinical and Drug Development Plans, Clinical Trial Applications, Pre-INDs, INDs, Scientific Advice and Meeting Briefing Documents, Orphan Drug and Paediatric plans/applications, Protocols, Investigator Brochures, IMPDs, CSRs, Marketing Authorisation Applications, New Drug Applications, Biologic License Applications, according to area of expertise.
- Representing clients in regulatory agency interactions and providing regulatory solutions to agency objections.
- Collaborating across jurisdictions and disciplines to deliver expert consulting services.
What we are looking for:
- 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).
- 8-10 years of drug development experience.
- 8-10 years of experience with either FDA, MHRA, and/or EMA, including negotiation. Regulatory experience may include time within a National Competent Authority.
- 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.
- A UK resident with the right to work in the UK without the need for sponsorship either now or in the future.
Why Scendea?
As part of our team, you’ll work alongside industry-leading experts in a fast-paced, supportive environment. 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.
You will also receive;
- A competitive salary.
- Generous bonus program, which rewards success.
- 26 days’ holiday plus public holidays, and discretionary additional days for birthday and work anniversary.
- Employer pension contribution.
- Provision 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.
Register your interest today
We are always looking for talented individuals to join our global team. If this sounds like the next step in your career, click “Apply” to register your interest.
-
Regulatory Affairs Consultant
14 hours ago
Bishop's Stortford, Hertfordshire, United Kingdom Scendea Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Scendea. As a key member of our regulatory affairs department, you will play a critical role in providing strategic and technical solutions to complex product development challenges.This includes:Developing innovative drug development plans, data gap analyses, and...
-
Regulatory Affairs Specialists
1 day ago
Bishop's Stortford, United Kingdom Scendea Full timeAre you looking to advance your career in regulatory affairs?At Scendea, we deliver market-leading scientific expertise and regulatory solutions to advance healthcare innovation worldwide. We are dedicated to streamlining medicinal product development, reducing time-to-market, and minimising costs for our biotech and pharmaceutical clients. If you are...
-
Regulatory Affairs Specialists
9 hours ago
Bishop's Stortford, United Kingdom Scendea Full timeAre you looking to advance your career in regulatory affairs?At Scendea, we deliver market-leading scientific expertise and regulatory solutions to advance healthcare innovation worldwide. We are dedicated to streamlining medicinal product development, reducing time-to-market, and minimising costs for our biotech and pharmaceutical clients. If you are...
-
Regulatory Affairs Specialists
18 hours ago
Bishop's Stortford, United Kingdom Scendea Full timeAre you looking to advance your career in regulatory affairs?At Scendea, we deliver market-leading scientific expertise and regulatory solutions to advance healthcare innovation worldwide. We are dedicated to streamlining medicinal product development, reducing time-to-market, and minimising costs for our biotech and pharmaceutical clients. If you are...
-
Strategic Regulatory Planning Specialist
14 hours ago
Bishop's Stortford, Hertfordshire, United Kingdom Scendea Full timeJob SummaryAs a Regulatory Affairs Specialist at Scendea, you will be responsible for providing regulatory guidance and innovative strategies across a wide range of medicinal product development activities.You will:Develop and implement regulatory strategies for complex products.Contribute to technical authorship and review of development regulatory...
-
Clinical Pharmacy Specialist
3 weeks ago
Bishop's Stortford, Hertfordshire, United Kingdom Ramsay Health Care Clinical Full timeRivers Hospital, part of Ramsay Health Care UK, is one of the leading providers of NHS and private patients' services in England.We are based on the Herts & Essex border and easily accessible from London and the Home Counties.The hospital opened with a focus on delivering high-quality care to our patients, ensuring they receive the best possible treatment...
-
HR Coordinator Specialist
4 weeks ago
Bishop's Stortford, Hertfordshire, United Kingdom EA First Compass House Full timeEA First Compass House is seeking an experienced HR Coordinator Specialist to join our dedicated HR team. This role will provide high-quality administrative support, involvement in employee lifecycle processes from recruitment onwards, and maintenance of employee data according to regulatory requirements.This exciting opportunity involves ownership of tasks...
-
Quality Assurance Specialist
3 weeks ago
Bishop's Stortford, Hertfordshire, United Kingdom Ernest Gordon Recruitment Full timeJob OverviewWe are seeking a Quality Assurance Specialist to join our team in the aviation industry.This role will be based in Bishop's Stortford and will involve working on quality engineering projects with a focus on ensuring high standards of quality and safety.About the RoleThe successful candidate will have experience in quality engineering or a related...
-
Vehicle Maintenance Specialist
17 hours ago
Bishop's Stortford, United Kingdom RecruitmentRevolution Full timeAbout the Job:">As a Vehicle Maintenance Specialist at Steven Eagell Toyota in Bishop Stortford, you will have the opportunity to develop your skills and knowledge in vehicle maintenance and repair. You will be responsible for carrying out vehicle services and repairs, examining vehicles, diagnosing non-routine defects, and reporting defects against...
-
Quality Specialist
7 months ago
Bishop's Stortford, United Kingdom STERIS Full timeAt STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. HOW YOU WILL MAKE A DIFFERENCE About you: Do you want to spend your working time making a difference in the world around you? Are you motivated by impactful work? Do you have a...
-
Engineering and Manufacturing Specialist
4 weeks ago
Bishop's Stortford, Hertfordshire, United Kingdom Steris Corporation Full timeCompany Overview:Steris Corporation is a leading provider of innovative healthcare and life science product and service solutions. Our mission is to help our customers create a healthier and safer world.About the Role:We are seeking an experienced Engineering and Manufacturing Specialist to join our team. In this role, you will be responsible for ensuring...
-
Accounting and Compliance Specialist
2 weeks ago
Bishop's Stortford, Hertfordshire, United Kingdom Rutherford Briant Full timeAbout Rutherford BriantWe are a progressive company that prioritises investment in our employees' growth and development. Our Hertfordshire office provides a supportive and collaborative environment where you can thrive professionally. As an AAT Finance Assistant, you will contribute to the success of our organisation by providing accurate and timely...
-
Plumbing and Heating Specialist
3 weeks ago
Bishop's Stortford, Hertfordshire, United Kingdom Kamro Ltd Full timeJob Title: Residential Plumbing and Heating TechnicianSalary: £42,000 per annumAbout the Role:We are seeking an experienced plumber and heating engineer with a strong background in residential installations and maintenance.Key Duties:Install, maintain, and repair domestic plumbing and heating systems to meet Gas Safe standards.Diagnose and resolve faults...
-
Mechanic Specialist
2 weeks ago
Bishop's Stortford, Hertfordshire, United Kingdom MPI Limited Full timeJob Title: Level 3 Vehicle TechnicianAt MPI Limited, we are seeking a highly skilled and experienced Level 3 Vehicle Technician to join our team in Bishops Stortford. As a key member of our workshop team, you will be responsible for carrying out scheduled vehicle service and repair work, in accordance with the relevant manufacturers' standards.The ideal...
-
Experienced Accountant
13 hours ago
Bishop's Stortford, Hertfordshire, United Kingdom Rutherford Briant Full timeAbout UsRutherford Briant is a reputable organization that values its employees. We believe in recognizing and rewarding hard work, which is why we provide a competitive salary of £50,000 - £65,000 per annum. As an experienced Accountant, you will play a crucial role in shaping our company's financial future. Your primary responsibilities will include...
-
Business Operations Officer
1 week ago
Bishop's Stortford, Hertfordshire, United Kingdom Ascend Airways Full timeJob SummaryAscend Airways is seeking an experienced Operations Control Specialist to join our team at London Gatwick. As a key member of our Operations team, you will play a crucial role in maintaining the safe and efficient operation of our fleet.Key ResponsibilitiesCoordinate and manage flight planning, crew scheduling, and aircraft routing to ensure...
-
Senior Design Manager
14 hours ago
Bishop's Stortford, Hertfordshire, United Kingdom Austin Fraser Full timeAbout the RoleAustin Fraser is looking for a talented Design Management Specialist to join their team in Central London. This is a fantastic opportunity to utilise your expertise in commercial fit out design management and take on new challenges.Key ResponsibilitiesDesign Management: Oversee the entire design process, from conceptualisation to completion,...
-
Material Handling Specialist
4 weeks ago
Bishop's Stortford, Hertfordshire, United Kingdom Thermo Fisher Scientific Full timeAbout the RoleWe are seeking a highly organized and detail-oriented Material Handler II to join our team at Thermo Fisher Scientific. This is an exciting opportunity to work in a fast-paced environment where you will be responsible for managing inventory, processing client orders, and ensuring accurate documentation.Job DescriptionPulling material from...
-
Level 3 Vehicle Technician
2 months ago
Bishop's Stortford, United Kingdom MPI Limited Full timeJob Title: Level 3 Vehicle TechnicianLocation: Bishops Stortford We have a requirement for 2 x Level 3 Vehicle Technician to work out of Bishops Stortford for a perm position. Salary - £28,000 per year plus Bonus (up to 2k per month).Working Hours -Monday to Friday &; alternate Saturdays8:30 -5:30 plus overtime available Benefits -Car Benefit Scheme...
-
Level 3 Vehicle Technician
2 months ago
Bishops Stortford, United Kingdom CV-Library Full timeJob Title: Level 3 Vehicle Technician Location: Bishops Stortford We have a requirement for 2 x Level 3 Vehicle Technician to work out of Bishops Stortford for a perm position. Salary - £28,000 per year plus Bonus (up to 2k per month). Working Hours - Monday to Friday & alternate Saturdays 8:30 -5:30 plus overtime...