Posts Tagged ‘Regulatory Affairs Jobs’
Friday, September 28th, 2012
GlaxoSmithKline is seeking approval for a further use of the drug Synflorix, a paediatric pnemococcal vaccine in Europe, reports Pharmaceutical-business-review.com.
The additional usage will be in order to put active immunisation in place against pneumonia for children from six weeks to five years old. GSK has submitted the application to the EMA as a variant to the marketing authorisation already in place.
Synfolrix is currently approved across the EU and in 90 other countries as an immunisation against invasive diseases and other illnesses caused by the same bacterium which can cause pneumonia in children under five. Over two thirds of these countries have already approved Synflorix for use against pneumonia.
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Tags: CK Clinical, ck regulatory, cka group, drug development, ema, EU, european medicines agency, European regulatory, glaxosmithkline, GSK, pneumonia drug, Reg Affairs Jobs, Reg Affairs Recruitment, Regulatory Affairs Jobs, Regulatory Affairs recruitment, synflorix
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Thursday, September 20th, 2012
Here are a few of our latest Regulatory Affairs roles in the UK:
Click on the links to find out more about the roles:
Shreeya Patel is recruiting an experienced Medical Writer to join an expanding team within a pharmaceutical company at their site based in Hertfordshire.
Click here to find out more
Shreeya Patel is recruiting an Associate Director of Regulatory Affairs and CMC to join a global pharmaceutical company based at their site in Hertfordshire on a permanent basis.
Click here to find out more
Shreeya Patel is recruiting an Associate Director of Regulatory Affairs and CMC to join a global pharmaceutical company based at their site in Hertfordshire on a permanent basis.
Click here to find out more
Please contact Shreeya for more details.
How to apply:
If you would like to apply or would like any information regarding these roles please contact Shreeya Patel on 01438 723 5670 or email spatel@ckclinical.co.uk
Not quite what you’re looking for?
Click here to search our current Pharmaceutical Regulatory Affairs roles online now.
Tags: associate director, CMC, Hertfordshire, medical awards, Medical Writer, Medical writing, Reg Affairs, Reg Affairs Jobs, Regulatory Affairs Associate, Regulatory Affairs Jobs, regulatory affairs jobs London, regulatory affairs officer, regulatory affairs recruitment uk, Regulatory Doc Scientist, Regulatory Jobs, Senior Associate, Senior Regulatory Affairs
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Tuesday, July 31st, 2012
Shreeya Patel at CK Regulatory is recruiting a Senior Regulatory Manager EU to join a global speciality pharmaceutical company in the South East on a permanent basis.
The job:
As the Senior Regulatory Manager EU you will be provided with an opportunity to gain experience across a range of submission types and strategies so this role would suit someone seeking to add to their current EU submission experience.
Responsibilities:
As Senior Regulatory Manager EU you will be responsible for the definition of regulatory strategy and subsequent implementation, in the EU and EEA regions. As Senior Regulatory Manager EU you will provide appropriate EU regulatory input to project teams to ensure planned drug development activities comply with EU guidelines and, in cases where they do not, you will provide a critical analysis of the risks and issues. As Senior Regulatory Manager EU you will define EU filing strategy (CP, MRP, DCP) identifying risks and issues. You will also ensure effective implementation of the filing plan, publishing and archiving of documents.
Qualifications:
As Senior Regulatory Manager EU you will be planning and implementing regulatory activities in support of lifecycle management. This role requires extensive experience in leading and running EU submissions in development, as well as scientific depth and the strong ability to influence. Someone who has recently held a position with autonomy would be preferable.
How to apply:
For further information about Senior Regulatory Manager EU role or to apply for the position please call Shreeya Patel on 01438 743 047 or email spatel@ckclinical.co.uk. Please quote reference CL24680 in all correspondence.
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Tags: jobs in the south east, Reg Affairs Jobs, Regulatory Affairs Jobs, regulatory affairs jobs London, regulatory affairs officer, regulatory affairs recruitment uk, Regulatory Jobs, Senior Regulatory Affairs, Senior Regulatory Affairs jobs, Senior Regulatory Affairs Manager jobs, Senior Regulatory Affairs Manager/AD, Shreeya patel, South East
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Monday, July 30th, 2012
Shreeya Patel at CK Clinical is recruiting a Regulatory Manager, UK and Ireland to join a global pharmaceutical company based in the South East on a permanent basis.
Responsibilities:
The Regulatory Manager, UK and Ireland role supports the implementation of regulatory operational activities in the UK/Ireland and provides regulatory support for the registration and post-licensing of EU medicinal products in the UK/Ireland regions. The Regulatory Manager, UK and Ireland will also support the implementation of regulatory strategy in Europe and the EEA and will provide regulatory support for the registration and post-licensing activities of medicinal products.
Qualifications:
As Regulatory Manager, UK and Ireland you must have had direct UK and Ireland submissions experience in both renewals and variations. It is important that you have a pharmaceutical background with good direct interaction with UK and Ireland Health Authorities. Experience of artwork implementation is also essential.
Benefits:
This role provides great opportunities to gain experience and exposure to working within the EU lifecycle team as you will get the chance to work on EU projects. You will also be given the opportunity to interact with Global CMC and Global Labelling.
How to apply:
For more information about this Regulatory Manager, UK and Ireland position or to apply for this role please contact Shreeya Patel on 01438 743 047 or email spatel@ckclinical.co.uk
Tags: Reg Affairs Jobs, Regulatory Affairs Associate, Regulatory Affairs Jobs, regulatory affairs jobs London, regulatory affairs officer, regulatory affairs recruitment uk, Regulatory Jobs, regulatory manager, Regulatory Manager for the UK and Ireland, Regulatory Manager for the UK and Ireland - South East, Senior Regulatory Affairs, South East jobs
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Tuesday, July 24th, 2012
Shreeya Patel at CK Regulatory is recruiting for a Global Regulatory Lead to join a leading healthcare company based in Surrey on a permanent basis.
Global Regulatory Lead Job Description
As Global Regulatory Lead you will be responsible for:
- Providing regulatory input into key projects and managing all regulatory activities related to that project.
- Working on projects where their particular expertise or experience can bring an additional benefit.
- Leading a team within Regulatory Affairs responsible for the registration of new products.
- Directing activities and managing the resources required to provide regulatory input into assigned projects and to develop effective regulatory strategies for assigned projects which meet business goals.
- Contributing specific expertise to Regulatory Authorities in a defined area and advise other members of the department/company as appropriate.
- Providing extensive knowledge of assigned products, including understanding of competitors and any additional area of regulatory expertise that is important for the business (eg. devices, biotech).
As Global Regulatory Lead your role will be fairly autonomous and decision making responsibilities will be defined by the tasks at hand limited to the maintenance and tactical level business implementations.
How to Apply:
Click here to apply online now >
For more information regarding this Global Regulatory Lead position, please contact Shreeya Patel on +44 (0)1438 743 047 or email spatel@ckclinical.co.uk. Please quote reference CL24823 in all correspondence.
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Click here to search our current Regulatory Affairs roles online now >
Tags: clinical regulatory affairs, clinical regulatory affairs jobs, Global Regulatory Lead Job in Surrey, pharma regulatory affairs jobs, Pharma regulatory affairs jobs uk, Pharma regulatory affiars jobs in uk, Pharmaceutical regulatory affairs jobs, Pharmaceutical regulatory affairs jobs in uk, Pharmaceutical regulatory affairs jobs uk, Regulatory Affairs Jobs, Regulatory affairs jobs in uk, regulatory affairs jobs uk, Shreeya patel, Surrey, uk
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Friday, June 29th, 2012
Shreeya Patel at CK Regulatory is currently recruiting for a Regulatory Associate Medical Devices to join a global clinical research organisation at their side based in Hertfordshire on a contract basis.
As Regulatory Affairs Associate your main purpose will be to:
- Provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures.
- Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects
- Acquire pertinent regulatory information from agencies and organizations
- Support regulatory agency interactions, communications, and submissions
- Review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.
- Coordinate and communicate with local CRAs to obtain relevant information
How to apply:
Click here to apply online now.
For more information regarding this Regulatory Associate Medical Devices, please contact Shreeya Patel on +44 (0)1438 870 024 or email spatel@ckclinical.co.uk. Please quote reference CL24467 in all correspondence.
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Click here to search our current Regulatory Affairs jobs online now.
Tags: Hertfordshire, medical device regulatory jobs, medical devices regulatory affairs jobs, pharma, pharma regulatory, pharma regulatory affairs, Pharmaceutical regulatory affairs jobs, Regulatory Affairs, regulatory affairs in pharma, regulatory affairs in pharma industry, Regulatory Affairs Jobs, regulatory affairs jobs uk, regulatory affairs medical devices, regulatory affairs medical devices jobs, Regulatory Associate Medical Devices Job in Hertfordshire, uk
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Thursday, April 5th, 2012
Here is a list of our latest Regulatory Affairs jobs. Please click on the links below to find out more and apply!
Regulatory Affairs Manager – London
Regulatory Affairs Manager II – London
Regulatory Affairs Manager (Labelling changes) – London
Associate Director, Regulatory Affairs – London
Regulatory Affairs Executive – contract – Hampshire
Regulatory Affairs Specialist (devices) – Lancashire
Medical Device Regulatory Interim Manager – Wales
By joining CK Regulatory on LinkedIn you will get the chance to network with other people who are also looking for a new Regulatory Affairs position.
You will also be able to directly ask the CK Regulatory team any questions you may have regarding your job hunt, as well as exclusive access to our latest jobs, videos, polls, careers advice and industry news.
Sound good? Join us on LinkedIn now!
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Tags: associate director, med device, Our Latest Regulatory Affairs Jobs - 5.4.2012, regulatory affairs executive, Regulatory Affairs Jobs, regulatory affairs manager london, Regulatory Affairs recruitment, regulatory affairs specialist
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Monday, February 20th, 2012
Cmed Clinical Services has appointed Geoff Fatzinger as Vice President of Global Medical and Regulatory Affairs, expected to bring his expertise from fifteen years as a regulatory professional, reports marketwatch.com.
Mr Fatzinger is expected to provide invaluable assistance in developing the new Medical and Regulatory Group established by Cmed, something he did successfully in his previous role at INC Research. Cmed CEO, David Connelly, believes Mr Fatzinger will be “a key building block in [Cmed’s] future business strategy.” He will be responsible for the company’s global Medical and Regulatory department.
Mr Fatzinger has a wealth of experience working with companies in Europe, Asia and North America and has spent his career in various areas around the world promoting and improving regulatory affairs, through his work and through lectures. He has said that “I am looking forward to the challenge, and making Cmed Clinical Services the industry’s first choice in quality partners for product development and product approvals.”
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Tags: asia, CK Clinical, ck regulatory, ck science, cka group, Clinical jobs, Cmed Clinical Services, Europe, INC Research, medical and regulatory affairs, north america, Reg Affairs Jobs, Regulatory Affairs Jobs, regulatory affairs jobs uk, Regulatory Affairs recruitment, regulatory affairs recruitment uk, science jobs
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Monday, February 13th, 2012
Meera Pattni at CK Regulatory is recruiting for a Senior Regulatory Associate to join a pharmaceutical company based in Buckinghamshire.
As Senior Regulatory Associate you will support the implementation of regulatory operational activities in Emerging Markets in Europe, Middle East and Africa, and provide regulatory support for the registration and maintenance of activities of medicinal products. You will also be required to develop and maintain knowledge of regulatory procedures in the region.
Further responsibilities of this Senior Regulatory Associate position include:
New Product Registration:
- Ensure effective implementation of the assembly and preparation of core files for Marketing Authorisation Applications.
- Work cross functionally to respond to questions from regulatory authorities to gain product approvals.
- Ensure effective planning and tracking of activities.
- Ensure effective coordination of the review and approval product related packaging as required, to ensure regulatory compliance.
- Support the definition and communication of regulatory strategy in support of new product registration, in line with commercial activities.
- Ensure that teams and functional groups are provided with clear, constructive regulatory advice and guidance.
Marketed Product Maintenance:
- Provide regulatory support for assigned products and inputs to project teams via Global Regulatory Teams.
- Ensure effective implementation of variations and renewals for the region.
- Implement regulatory activities in support of lifecycle management and maintenance of the region.
- Work with regulatory staff “in country” to support the markets.
- Provide clear communication to “in country” and global regulatory staff on planned activities and priorities.
As Senior Regulatory Associate, you will have the following qualifications, skills and experience:
- Life sciences degree.
- Knowledge of international pharmaceutical regulations and guidelines.
- Extensive regulatory affairs experience, including a successful track record in the registration and maintenance of pharmaceutical products within Europe.
- Excellent organisation, planning and negotiation skills.
- Excellent verbal and written communication skills.
- Good interpersonal skills.
- Ability to work collaboratively.
How to apply:
Click here to apply online now.
To find out more, please contact Meera Pattni on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23685 in all correspondence.
Click here to search our Regulatory Affairs roles in the South East.
Tags: pharmaceutical company, Regulatory Affairs Jobs, regulatory affairs jobs in Buckinghamshire, regulatory affairs jobs in south east, senior regulatory affairs jobs Buckinghamshire, Senior Regulatory Associate Job in Buckinghamshire
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Wednesday, February 8th, 2012
As reported by Business Weekly, the Pharmaceutical Regulatory Affairs organisation, ELC Group has moved their headquarters from Prague to Cambridge, UK.
The Regulatory Consulting and Services provider has moved to the Cambourne Business Park in the hope this will help booster their acquisitions and help them increase their presence in South Asia.
ELC Group grew rapidly in 2011, fuelled by the demand for their regulatory affairs consulting sercices. They have also seen strong customer demand for their Pharmacovigilance and regulatory submissions service.
Marco Rubinstein, CEO of ELC Group, said: “In tough market conditions, we have enjoyed a year of truly outstanding revenue growth. This really demonstrates the value our global customers are deriving from our core offering, and provides an excellent platform for the strategic plans we have in place to expand the breadth and depth of ELC Group’s capabilities.
“The establishment of our new global headquarters provides us with an optimal location from which to execute our growth ambitions and cement our leadership position in the regulatory affairs service market.”
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Tags: Cambridge, elc group, pharmaceutical regulatory affairs company, Pharmaceutical Regulatory Affairs Company moves HQ to Cambridge, Regulatory Affairs Jobs, Regulatory affairs jobs Cambridge, regulatory affairs recruitment Cambridge
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