An outstanding opportunity for a Senior Regulatory Affairs Professional to join a well established Regulatory Consultancy Company and play an instrumental role in the growth of the business.
Duties will include:
management of product licence registration and post registration activities with the appropriate regulatory authorities on a global basis
preparation of any regulatory dossiers and/or supporting documentation
supporting clients with the appropriate documentation to facilitate registration/maintenance of products
providing leadership and guidance to junior stuff and ensuring site activities comply with regulatory requirements.
reviewing and interpreting regulatory guidelines.
Providing in house training on regulatory topics as required
Supporting marketing and business development activities. This may include (but not be limited to):
- advising on regulatory activities, timelines and costs for new business proposals as required
- participating in new business meetings, kick off meetings and project meetings as required.
The candidate should be qualified in Life Sciences and have broad experience in pharma regulatory environments for US/EU markets. Sound knowledge of Global Regulatory Procedures, including marketing applications, negotiation and product licensing knowledge, proven success in agency influencing and negotiation are essential. Broad level of experience within the Pharmaceutical industry with knowledge of Regulatory Affairs and knowledge of product development is a must.
If you feel you have the relevant skills and experience for this role please send your application to jobs@elc-group.com. Please quote reference S_RAPM in all correspondence.
An outstanding opportunity for a Regulatory Affairs professional to join a well established Regulatory Consultancy Company and play an instrumental role in the growth of the business. You will be responsible for identifying and developing new business to ensure the regulatory sales targets are met or exceeded.
The person
Suitable candidates will have a background in sales / marketing of a scientific consultancy service. You will have sound knowledge of Global Regulatory Procedures, including marketing applications, negotiation and product licensing knowledge, proven success in agency influencing and negotiation. Broad level of experience within the Pharmaceutical industry with knowledge of Regulatory Affairs and knowledge of product development is a must.
You must have excellent communication skills, be a good listener, be commercially minded and able to develop complex and diverse proposals / solutions for clients’ requirements.
You will have the ability to network with colleagues and co-workers appropriately and to manage the communication to and collaboration of decision-making members of each project team.
Typical activities may include:
Providing regulatory strategy and technical consultancy for the Regulatory Affairs Business Development Team and Project Management Team as well as regulatory consultancy and strategic advice to the clients;
Reviewing and providing technical advice to prepare regulatory submissions;
Contributing to development and implementation of global and regional regulatory functions;
To assist in business development in securing new business and making presentations to clients;
Maintaining and developing relationships with existing customers via meetings, telephone calls and emails;
Visiting potential customers to prospect for new business;
Acting as a contact between a company and its existing and potential markets;
Negotiating the terms of an agreement and closing sales;
Gathering market and customer information;
Representing the organization at trade exhibitions, events and demonstrations;
Negotiating variations in price, delivery and specifications with managers
Advising on forthcoming product developments and discussing special promotions;
Liaising with Project Managers to check on the progress of existing orders;
Recording sales and order information and sending copies to the sales manager;
Reviewing own sales performance, aiming to meet or exceed targets;
Gaining a clear understanding of customers’ businesses and requirements.
Offer:
• Competitive basic salary
• Attractive commissions package with no caps
• Bonuses
As reported by the Morpeth Herald, the leading pharmaceutical contract development and manufacturing organisation, Piramal Healthcare, has received a £17m investment package from the Regional Growth Fund. This will create 46 pharmaceutical jobs.
Piramal specialise in the manufacture of active pharmaceutical ingredients and current export more than 100 of these products worldwide. The company will be using the investment to help increase its competitive edge when trading internationally. This was explained by Site Lead, Jarrett Palmer, “This is most welcome news. The funding will go a long way towards supporting our ambitious growth plans over the next five years. The grant will enable us to invest in new capabilities which will enable us to enter new markets worldwide.”
Jim Gleeson at CK Science is currently recruiting for a Director of Quality Assurance to join a successful molecular diagnostics company based in the North West, UK.
The role:
As Director of Quality Assurance, you will oversee all Quality Assurance activities for the manufacture of in-vitro diagnostics. Further responsibilities will include:
Management of the company’s Quality System
Close interaction with senior management and international regulatory authorities
Ensuring the highest levels of compliance with all applicable standards and regulations
Mentoring and development of staff across QA, QC and Compliance
Selection of methods, techniques and evaluation criteria in order to obtain robust results
The ideal candidate:
Jim is looking for candidates with the following skills, experience and qualifications:
Extensive GMP QA management experience, ideally within the diagnostics / medical device arena
Experience of hosting and managing FDA and other regulatory inspections (ISO 13485 would be particularly useful)
A background in ISO 13485 management would be advantageous
Excellent communication skills
How to apply:
For more information or to apply for this Director of Quality Assurance position, please contact Jim Gleeson on 01438 870027 or email jgleeson@ckclinical.co.uk. Please quote reference CL22921 in all correspondence.
Reena Dhana is currently recruiting for a QA Engineer to join the Research and Development facility leading Diagnostic and Medical Device organisation based in Bedfordshire, UK.
As QA Engineer, you will work across various aspects of the organisation and will be responsible for managing all Quality and Compliance within Research and Development. You will also be responsible managing a team of Design Compliance Facilitators.
The ideal candidate:
Reena is looking for candidates who have:
a degree in Engineering or Scientific Discipline (or equivalent)
Demonstrable experience in Design Controls and Product Development gained within the Medical Device/Diagnostics (or equivalently regulated industries).
Previous project management experience
Lead Auditing qualifications would be desirable
How to apply:
For more information or to apply for this QA Engineer position, please contact Reena Dhana at CK Science on 01438 723 500 or email rdhana@ckscience.co.uk. Please quote reference ST22863 in all correspondence.
Victoria Walker at CK Science is recruiting for Project Scientist to join ACAL Energy. ACAL Energy Ltd is the world’s leading developer of low cost Proton Exchange Membrane (PEM) Fuel Cells systems, powered by ACAL Energy’s proprietary platinum free cathode technology (FlowCath).
Based in Runcorn, Cheshire, they are now recruiting for a Project Scientist to join their Chemistry team to work in the area of Polyoxometalate Chemistry, and are currently working on an exclusive basis with CK Science for this recruitment campaign.
Job purpose:
To design, synthesise, evaluate and deliver new catalyst and mediator materials based on inorganic cluster compounds and associative structures which improve the performance of the ACAL Energy FlowCath technology.
Major challenges:
To deliver catalyst and mediator materials based on inorganic cluster/associative structures which display improved performance in the ACAL Energy fuel cell and meet product and market needs.
To identify suitable materials for catalyst and/or mediator roles and design and execute synthetic routes to these species.
To characterise target materials and evaluate performance, particularly in relation to electrochemical and catalytic properties.
Key accountabilities:
Deliver catalyst and/or mediator materials based on inorganic cluster/associative structures which display improved performance in the ACAL fuel cell.
Apply chemical knowledge and understanding to identify and design target materials to meet criteria.
Design and execute synthetic routes to target materials, with consideration of commercial implications.
Complete COSHH and risk assessments for all experimental work and conduct work in a safe manner at all times.
Fully characterise target materials.
Evaluate performance related properties of catalyst and mediator materials, in particular by assessing electrochemical and catalytic properties.
Produce high quality written technical reports and present results and findings at regular intervals.
Identify patent opportunities arising from the work undertaken.
Liaise with internal fuel cell test team to demonstrate the fuel cell performance of lead materials.
Take responsibility for delivering agreed project outputs and contribute to the delivery of the key objectives for the Chemistry team and the company.
Technical skills and knowledge:
Knowledge and understanding of inorganic chemistry
Competency in practical inorganic synthesis, with experience of inorganic cluster/association complex synthesisin aqueous solution preferred
Ability and enthusiasm for laboratory working
Experience and understanding of electrochemical kinetics and/or catalysis is preferred
Competent user of literature searching tools
Broad chemical understanding for the rational design of target materials
Logical approach to problem solving and decision making
Creative approach for the generation of chemical solutions
Personal skills and attributes:
Must be a team player with good communication and affiliativeskills to build strong internal relationships
Results oriented and standards driven, focused on delivery
Commercially aware; understanding what they are trying to achieve and to have a degree of entrepreneurialism
Has a critical nature to question status quo and challenge norms to develop innovation or improvements
Proactive style and flexible approach with a willingness to learn new techniques
Able to work independently in a self motivated manner
Able to demonstrate a practical approach to problem solving using creative thinking
Desire to further fundamental understanding and see technical advancements through to completion
Job experience:
Educated to degree level or equivalent in Chemistry with either a relevant PhD qualification or equivalent experience
gained in a relevant industrial role
Application of chemistry knowledge to the design, synthesis and evaluation of materials
Practical laboratory working experience
Experience of applying electrochemical or catalytic understanding to inorganic materials would be advantageous
How to apply:
For more information or to apply for this Project Scientist position, please contact Victoria Walker on 0114 283 9956 or email vwalker@ckscience.co.uk. Please quote reference SH22762 in all correspondence.
Andrew Bolton at CK Science is recruiting for a number Engineering Technicians to join a leading Chemical Manufacturer based in Hertfordshire, UK.
The company
Andrew’s client is a Chemical Manufacturer specialising in Catalyst applications for the Automotive industry.
Andrew is looking for several Engineering Technicians to join the company’s Engine, Vehicle and Synthetic Departments based from their state of the art facilities in Hertfordshire.
Roles available:
Engine Test Technician – You will be involved in carrying out catalyst preparation; operation and support of engine test beds; data checks and maintenance of the engine test facility. This role is shift based, consisting of day and late shift working patterns.
Vehicle Test Technician – You will be involved in carrying out emissions testing; performing test cycle driving; data processing; catalyst changing as well as general workshop based tasks. This role is on a day shift basis.
Synthetic Test Technician – You will be involved in the operation of test rigs to ensure the performance of their catalyst and other emission control technologies. Your duties will include preparing and loading test pieces; handling of synthetic exhaust mixtures; programming and running test sequences as well as carrying out rig maintenance. This role is shift based, consisting of day and night shift working patterns.
The ideal candidates:
To be considered for these positions, you will have either a vocational qualification in a Mechanical or other Engineering discipline (or equivalent) OR demonstrated experience in a Test Laboratory / Workshop or Quality Control environment within the Automotive, Chemical or a Manufacturing based industry.
How to apply:
For more information or to apply, please contact Andrew Bolton at CK Science on 01438 723 500 or email abolton@ckscience.co.uk. Please refer to ST22630 in all correspondence.
Oil and gas company BP are struggling to find skilled engineers to expand their North Sea operations, reports the BBC.
The growth of the North Sea oil and gas fields, expected to create hundreds of jobs, seems to have stagnated as Trevor Garlick, head of BP’s North Sea operations, said the company cannot find the correct people to fill the roles. He adds that “getting hold of the right people is a real issue for us.”
BP views the North Sea as a ‘training ground’ where the most capable employees are developed before being moved overseas. Mr Garlick says that whilst “we are hiring a lot of people, but we are also an exporter of a couple of hundred people to other regions.” It is believed that the oil and gas industry is expected to create over 15,000 jobs in the next five years, though companies complain of the same problem as BP – being able to find qualified staff to fill positions.
The BBC has reported that over the next ten years 1,500 jobs could be created in the energy industry in Scotland.
Scottish Power’s recruitment announcement is reported at a time when the employment statistics continue to be a worry. The jobs are needed to complete an upgrade of the power grid in line with the government’s renewable energy targets. The investment into the power grid and an “aging workforce” mean new staff are needed.
£3 billion is expected o be spent over the next ten years in order to improve over 500 miles of power lines, giving three times more capacity to carry power through the grid. Graduate engineers, apprentices and technicians are expected to be the people targeted for the new jobs. Scottish Power’s announcement, it is hoped, will help in reducing the unemployed across Scotland.
A waste recycling plant is set to be opened in Darwen, Lancashire, pending approval by the council, reports the BBC.
SITA UK, who are developing the £5 million site believe the project will create up to 30 jobs at a site on Lower Eccleshill Road. The Materials Recycling Facility is designed to sort 35,000 tonnes of material annually, including plastic, cans, card and paper from Lancashire commercial businesses, rather than household waste.
The plans for the site are expected to be sent to the Council by the end of August in order to develop the facility as soon as possible. The facility will allow for materials to be unloaded, sorted and bailed within the site, excluding glass, which will have to be sorted outside in a specially designed area.
