Senior Regulatory Affairs Officer – Edinburgh

Barney Smith is recruiting for a Senior Regulatory Affairs Officer to join a Contract Research Organisation based in Edinburgh on a permanent basis.

Responsibilities include managing the product licence registration process with the appropriate regulatory authorities on a worldwide basis.

To be considered for this role you must have a proven track record of working in regulatory affairs within a medical devices, diagnostics, biologics or virology environment. Our client is growing rapidly and will soon be a global leader in their field so this is a great opportunity to join.

For more information or to apply click here >

 

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Regulatory Affairs Manager – Edinburgh

Barney Smith is recruiting for a Regulatory Affairs Manager to join a Contract Manufacturing Organisation based in Edinburgh on a permanent basis.

Responsibilities include managing the product license registration with regulatory authorities on a worldwide basis and managing the regulatory affairs team. You will also be expected to manage, prepare and maintain regulatory documentation to ensure compliance with quality standards and FDA Regulations.

This could be a great opportunity for you if you have significant experience in managing a Regulatory Affairs department within a diagnostic, medical device, virology or immunology related environment. As this client is experience substantial growth due to the success of their core business so this is an opportunity to join a company at an exciting time.

Click here for more information or to apply >

 

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Global Raw Material Compliance Coordinator

Jason at CK Science is recruiting for a Global Raw Material Compliance Coordinator to join a global pharmaceutical company at their UK Site in London/Kent on a full time, permanent basis.

Our client designs and supports advanced coating systems, modified release technologies and functional excipients for pharmaceutical dosage form and are looking for someone to manage the Raw Material Risk Assessment programme.

If you have experience in a QC, A or regulatory affairs at an intermediate level, and are competent at the day to day management of base raw material data and specifications in the Oracle Quality Module and Master items, our client would like to speak to you.

For more information on this role and to apply click here

 

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Pharmaceutical Technical Executive – London, UK

Jason Johal at CK Science is recruiting for a Pharmaceutical Technical Executive to join an international speciality Pharmaceutical company based in London on a 6 month initial contract.

This is an excellent opportunity to join a growing pharmaceutical company with several new products launched this year and several more in the pipeline. As Pharmaceutical Technical Executive you will gain excellent development experience, and attractive salary and excellent personal development opportunities.

The Role:

As Pharmaceutical Technical Executive you will:

– Provide a technical support service to the Medical and Regulatory Affairs Unit

– Advise on all relevant product issues

– Approve technical documentation provided by third parties

– Investigate and resolve technical issues from manufacturers

– Be involved in site transfer projects

– Be responsible for compliance documents

– Be responsible for expert document writing

– Apply for licences

 

Qualifications, Skills and Experience:

The successful Pharmaceutical Technical Executive will have the following qualifications, skills & experiences:

– BSc in Pharmacy or Chemistry or equivalent

– Relevant technical experience gained in the pharmaceutical industry

– Regulatory experience of CMC documentation (essential)

– Manufacturing experience (essential)

– CMC sections experience

– Document control experience (essential)

– Regulatory knowledge needed including regulatory licensing

– Product development experience

– Technical knowledge across a range of dosage forms (tableting experience is essential)

– Auditing experience

– Problem solving experience (essential)

– Experience dealing with 3rd party manufacturers (advantageous)

– Technical Transfer knowledge

– API & Finished product experience

 

 

How to Apply:

 

Jason Johal at CK Science is recruiting for a Pharmaceutical Technical Executive – London

Please contact Jason for more details.

Click here to apply online now.

For more information regarding this Pharmaceutical Technical Executive position, contact Jason Johal via email: jjohal@ckscience.co.uk or telephone: 01438 723 500.Please quote reference ST24799 in all correspondence.

 

 

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Pharmaceutical Technical Executive – London   Pharmaceutical Technical Executive – London   Pharmaceutical Technical Executive – London   Pharmaceutical Technical Executive – London

 

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Regulatory Affairs Professional Job – Cambridge, UK

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

 

How to apply:

Please reply with your CV and cover letter to jobs@elc-group.com

Location: Cambourne, Cambridge

Ref: RABD_1

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Regulatory Affairs Manager Job – North Scotland

Our client, a Scottish diagnostics company require a Regulatory Affairs Manager on a temporary basis to cover maternity leave.

Reporting to the Quality Assurance/Regulatory Affairs Director you will be responsible for a small team ensuring company activities are in compliance with regulations applicable to the diagnostics industry.

To be considered for this Regulatory Affairs Manager position, you must have the following skills and experience:

  • Have experience of working within or in close interaction with the RA team in relation to regulatory submissions or verification activities.
  • Be knowledgeable about the requirements of at least one of the following areas, IVD Directive, FDA 510k submissions, cGMP requirements as they impact on RA.
  • Have experience in interacting with external partners and regulatory agencies including the FDA.
  • Have the ability to build key relationships within the senior management team to promote and direct RA within the organisation.
  • Have supervisory experience.
  • Educated to degree level in a life science subject or have demonstrable experience in a regulatory affairs position.

 

How to apply

For more information or to apply for this Regulatory Affairs Manager position, please contact Graeme Pallas on 0191 384 8905 or email gpallas@ckscience.co.uk.

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Regulatory Conformance Officer Job – County Durham

Our client, a major pharmaceutical company located in County Durham, seek a Regulatory Conformance Officer to join their company based in County Durham on a temporary basis.

Responsibilities:

The main responsibilities of this Regulatory Conformance Office  role are to minimise risk to the supply chain as a result of non-compliance activities, provide compliance solutions, help meet the training needs for the site and represent regulatory conformance in tech-transfer project teams for new product introduction.

Person Specification:

The ideal candidate will have knowledge of GMP, CFR, FDA, MHRA and other regulatory authority requirements, have excellent communication skills, demonstrate understanding of OE tools and techniques, new business introductions, new business applications and supply chain operations.

Apply Now

For more information or to apply for this Regulatory Conformance Officer position, please contact Graeme Pallas at CK Science on 0191 3848905 or email gpallas@ckscience.co.uk.

Alternatively, click here to apply for this Regulatory Conformance Officer position online now.

Not quite what you’re looking for? Click here to search our current science jobs online now.

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Regulatory Affairs Officer (Chemical) London, UK

Our client, a world leading Chemical Distributor, are currently looking for a Regulatory Affairs Officer to join their UK flag ship facilities based in London, UK.

Working as a Regulatory Affairs Officer, you will be responsible for providing regulatory support to all departments on site including designing and outlining regulatory procedures as well as performing regulatory checks and auditing of all products (ISO 9001, ISO 14001, OHSAS 18001, GHP,REACH) and packaging (CLP) in line with industry quality standards. Your duties will also see you working closely with suppliers and customers to ensure completion and sending out Safety Data Sheets (SDS) and attending 3rd party audits.

This is an outstanding opportunity to join a leading Chemical Distributor who continues to have success across the UK and Europe. In return they offer an attractive salary and benefits package.

To be considered for this Regulatory Affairs Officer role, you will have a degree in Chemistry or a relevant discipline (or equivalent), demonstrated understanding & experience of working to chemical regulatory standards including ISO 9001, ISO 14001, OHSAS 18001 and REACH as well as knowledge of safety data sheets (SDS). Experience of auditing to ISO standards and/or within a supervisory or managerial function would be highly advantageous but it is not essential.

Apply Now

For more information, or to apply for this Regulatory Affairs Officer position, please contact Andrew Bolton at CK Science on 01438 870 013 or email abolton@ckscience.co.uk. Please quote reference ST20378 in all correspondence.

Alternatively, click here to apply for this Regulatory Affairs Officer position online now.


Meet Andrew – CK Science’s Specialist Chemical Industry Recruitment Consultant for the South, UK


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AstraZeneca to Cut 1,200 UK Pharmaceutical Jobs

Science Job CutsAs reported on the Times Online, the Pharmaceutical Industry giant, AstraZeneca plans to cut 1,200 UK Pharmaceutical jobs. The job cuts are a result of the company’s suspension of their research into various disease areas.

The company plans to close its research and development facility based in Leicestershire, along with another small plant in Cambridge.  Pharmaceutical development work at the Avlon facility near Bristol will also cease. Some of the workers will move to the company’s Alderly Park in Cheshire which is AstraZeneca’s largest research and development plant.

This will come as disappointing news to the Government, who created the Office of Life Sciences last year in a bid to increased the number of science and pharmaceutical jobs. The head of the Office of Life Sciences, Lord Drayson, said “I’m obviously disappointed that AstraZeneca is closing Charnwood, but the announcement that Alderley Park will become one of AstraZeneca’s top three global R&D sites shows that the UK remains an attractive location for investment in pharmaceuticals.”

Earlier in the year, AstraZeneca announced that they planned to cut 8,000 jobs around the world by 2014, including 3,500 in research and development, as part of a large-scale refocusing of the business.

Have you been effected by redundancy? Search for pharmaceutical jobs in your area now.

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