Senior Regulatory Specialist

2 weeks ago


Abingdon, United Kingdom Coburg Banks Limited Full time

A high-growth global healthcare company is currently looking for a Senior Regulatory Specialist to join their UK headquarters in Abingdon, Oxfordshire. You would assist the Director of Regulatory Affairs and the Head of Regulatory Affairs with the company'sregulatory process, leading to timely product approval for both new and existing products.
The role will suit individuals with significant experience within IVD/MD Regulatory Affairs, with substantial previous submissions experience, ideally in a medical device/diagnostics field, including experience with some or all of US FDA, EU, China NMPA, andJapan PMDA.
Offering an attractive salary dependent on experience plus benefits including bonus, pension scheme, plus life and medical insurance, this is a fantastic chance to contribute to great science driven by intellect and curiosity, and work with great people unitedin doing important work and being valued for it.
**The Role**
The company house the only national TB testing laboratory exclusively dedicated to performing the T-SPOT.TB test and are committed to providing the highest quality results and service to customers and patients.
As Senior Regulatory Specialist you would play a key role in regulatory process, providing global regulatory support to Sales and Commercial teams for ongoing requests for documents and information. Key tasks will include
- Ensuring verification / validation activities plus risk management are carried out to support regulatory requirements
- Supporting facilities to ensure that any regulatory needs are covered
- Assisting with Internal and External audits to agreed standards, with regard to the regulatory requirements
- Taking a central role in the preparation for and implementation of the requirements of global IVD Regulations
- Educated to degree level or higher or with significant relevant experience within IVD/MD Regulatory Affairs
- Excellent knowledge of Quality Management systems, especially ISO 13485 and cGMP
- Substantial previous submissions experience, ideally in a medical device/diagnostics field, and including experience with some or all of US FDA, EU, China NMPA, and Japan PMDA
- Understanding of the scientific, biological and technical issues involved in developing diagnostic assays
- Experience in the line management of junior staff
- Experience of the conduct of Internal and External Quality audits
- Ability to operate at manager level and demand respect of peer group
**The Company**
Across the globe, the company is driven by the expectation of excellence. Their proprietary immunology platform is already generating a major impact on human life by creating more effective ways to test for diseases like TB and transforming the diagnosticsmarket place in the process. At the same time, in their commitment to giving passionate and creative people the freedom to explore their full potential they are working to set a new standard for careers in the sector.
IND3Coburg Banks Limited is acting as an Employment Agency in relation to this vacancy.


  • Regulatory Specialist

    4 weeks ago


    Abingdon, United Kingdom Revvity Full time

    This position is offered as a fixed term contract (FTC) of circa 9 months and is responsible for Global Regulatory activities within Oxford Immunotec (Revvity) Role Description: Overall responsibilities: To assist the Regulatory team with the Company’s regulatory process leading to timely product approval for both new and existing products in line...


  • Abingdon, Oxfordshire, United Kingdom Adaptimmune Full time

    Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Our company...


  • Abingdon, United Kingdom Adaptimmune Full time

    PRIMARY RESPONSIBILITY  Under the supervision of Senior Regulatory Affairs staff, the Manager, Regulatory Affairs is responsible for developing, implementing, and leading short- and long-term global regulatory strategies that support the success of products throughout their lifecycle. Serves as the primary liaison to regulatory agencies and leads...


  • Abingdon, Oxfordshire, United Kingdom Adaptimmune Therapeutics PLC Full time

    Adaptimmune is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immunotherapy products for people with cancer. The Company's unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. Our...


  • Abingdon, United Kingdom Evotec Full time

    We currently have a number of openings within our Pilot Plant for shift working Pharmaceutical Operator Specialists. If you have just graduated in either Chemistry or other related discipline, this could be the opportunity that you are looking for, alternatively you may already have some experience in this area and be looking for your next career...


  • Abingdon, United Kingdom Evotec Full time

    Our Company Evotec, Aptuit’ s parent company, is a leader in the discovery and development of novel therapeutics of all modalities with operational sites in the UK, Europe (Germany, Italy and France) as well as the US. Aptuit Oxford provides integrated Chemistry, Manufacturing and Control capabilities to fully support drug substance development and GMP...


  • Abingdon, Oxfordshire, United Kingdom Summer-Browning Associates Ltd Full time

    We are looking for a Senior Commercial Procurement Specialist to work within the nuclear sector. Location: Hybrid working - Culham, Abingdon About the role : You will be responsible for managing the pipeline of Procurement activities; Contracts Register and Commercial Continuous Improvement Framework to support the annual budget process working closely...


  • Abingdon, Oxfordshire, United Kingdom Immunocore Full time

    Job Details: Associate Director, Regulatory Affairs CMC Full details of the job. Vacancy Name Vacancy Name Associate Director, Regulatory Affairs CMC Vacancy No Vacancy No VN194 Employment Type Employment Type Permanent Location of role Location of role Abingdon About the Company About the Company Immunocore (NASDAQ: IMCR) is a pioneering,...


  • Abingdon, United Kingdom Evotec Full time

    We currently have a number of openings within our Pilot Plant for shift working Pharmaceutical Operator Specialists. This is a permanent position starting ASAP, working 12-hour shifts (days and nights). Role & responsibilities - Operate the pilot plant reactors and ancillary equipment following all current procedures (IOPs, BPGs, etc.) to maintain high...


  • Abingdon, United Kingdom Mars Recruitment Full time

    **Senior Manufacturing Technician, Abingdon, £33,000 - £39,000 plus benefits**: A global specialist manufacturer with an amazing history and presence within their industry is looking to recruit several mechanically biased Senior Manufacturing Technicians. Joining a talented Manufacturing team, the Senior Manufacturing Technician willensure that the company...

  • Accounting Supervisor

    4 weeks ago


    Abingdon, Oxfordshire, United Kingdom Hays Senior Finance Full time

    The team has been engaged by an up-and-coming biotech business based in the Abingdon area to find the latest addition to the company, a Management Accountant. Bank reconciliation Balance sheet reconciliations Fixed assets including, posting depreciation, maintaining fixed asset register, monitoring and reviewing capital expenditure US accounting...


  • Abingdon, Oxfordshire, United Kingdom Hays Senior Finance Full time

    Full time Our client is an outsourced business services company that specialises in providing back-office services to start-ups or existing businesses within the Financial Services industry, with a particular focus on SME businesses in the investment management sector. Due to continued growth, we have exciting opportunities for a full-time Accountant...


  • Abingdon, Oxfordshire, United Kingdom Immunocore Full time

    Associate Director, Regulatory Affairs CMC Vacancy Name Associate Director, Regulatory Affairs CMC Employment Type Permanent IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious...


  • Abingdon, Oxfordshire, United Kingdom Informa Full time

    This people-focused function allows for improved communication, quick response rates, clear processes, and accurate data. In short, the People Operations Excellence team ensures a seamless end to end colleague experience. Help us progress human progress through knowledge! As a People Operations Excellence Senior Specialist, you will aid in our mission...


  • Abingdon, Oxfordshire, United Kingdom Immunocore Full time

    Job Details: Senior Manager, Commercial Supply Chain Full details of the job. Vacancy Name Vacancy Name Senior Manager, Commercial Supply Chain Vacancy No Vacancy No VN238 Employment Type Employment Type Permanent Location of role Location of role Abingdon About the Company About the Company Immunocore (NASDAQ: IMCR) is a pioneering,...


  • Abingdon, United Kingdom Revvity Full time

    The Senior Project Manager will be part of the PMO and be responsible for supporting program management activities across the Company. This will include delivery of new product development projects for IVD products for infectious disease, automation products to automate clinical testing and corporate projects where appropriate. It is the responsibility of...

  • Senior Tree Officer

    4 weeks ago


    Abingdon, United Kingdom South Oxfordshire District Council Full time

    Job Advert **Location**: Abingdon **Contract Type**: Permanent **Hours**: Full time, Permanent **Salary**: £45,568 to £50,764 per year **Closing Date**: 3 October 2023. South Oxfordshire and the Vale of White Horse District Councils are seeking an experienced and qualified arborist to lead the council’s Forestry Team. This is an exciting and varied...

  • Senior Tree Officer

    4 weeks ago


    Abingdon, United Kingdom South Oxfordshire District Council Full time

    **Location**: Abingdon **Contract Type**: Permanent **Hours**: Full time, Permanent **Salary**: £45,568 to £50,764 per year **Closing Date**: 3 October 2023. South Oxfordshire and the Vale of White Horse District Councils are seeking an experienced and qualified arborist to lead the council's Forestry Team. This is an exciting and varied role working...


  • Abingdon, Oxfordshire, United Kingdom Allied Healthcare Full time

    A fantastic opportunity for an organised and diligent Senior Property Manager to join a leading independent lettings agency within their office in Abingdon. This is a brilliant opportunity for a competent Property Manager to join an excellent company who can offer unrivalled long term progression. Senior Property Manager – Benefits Team lunches. ...


  • Abingdon, Oxfordshire, United Kingdom Immunocore Full time

    Job Details: Senior Manager, Manufacturing and Outsourcing Full details of the job. Vacancy Name Vacancy Name Senior Manager, Manufacturing and Outsourcing Vacancy No Vacancy No VN232 Employment Type Employment Type Full Time Location of role Location of role Abingdon About the Company About the Company Immunocore (NASDAQ: IMCR) is a pioneering,...