Posts Tagged ‘pharmaceutical jobs’

GSK Parkinsons Trials Post Positive Results

Tuesday, August 16th, 2011

Pharmaceutical giant GlaxoSmithKline’s new Parkinson’s drug has been seen to help patients retain their motor skills following the medication wearing off, reports inpharm.com.

In a phase III trial, the drug significantly increased patients’ time without needing to use the drugs whilst their motor skills did not decline any further. The drug decreased patients off time, where they suffer from Parkinson’s symptoms, by 33.5% from the standard baseline. This represents over two hours more time that patients report that they are symptom free following taking their medication.

Impax Pharmaceuticals, who developed the drug with GSK, said they are “excited to report these positive results.” Under the agreement between the companies, Impax holds the rights to the drug in the US and Taiwan, with GSK holding the rights in every other market. GSK plans to apply for marketing rights in the EU early in 2012.

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Pharma Giant Pushes Epilepsy Drug as Treatment

Thursday, July 28th, 2011

Pharmaceutical giant Eisai has been granted an extended European licence for the drug Zonegran, reports Pharmaceutical Business Review.

Zonegran, an antiepileptic drug, has been accepted as an adjunctive therapy for epilepsy treatment and Eisai are applying to have the drug used as a stand alone therapy for epilepsy patients with partial seizures.

The application for a mono-therapy was given following a blind, random trial comparing Zonegran to another treatment and involved nearly 600 newly diagnosed patients. The trial showed that those who used Zonegran as a mono-therapy tolerated the drug well and found it was effective in controlling symptoms.

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Success for Novartis’ Regulatory Affairs

Thursday, July 7th, 2011

Novartis’ regulatory affairs staff have secured a new treatment for tuberous sclerosis complex in Europe, reports cslrecruitment.com.

The European Medicine Agency’s Committee for Medicinal Products for Human Use reached the decision following phase II trials showing patients who could not undergo surgery improved significantly. If approved, the treatment will be the first in the EU for this condition.

Herve Hoppenot, oncology president at Novartis, believes this “reflects the commitment Novartis has made to develop innovative therapies to help address unmet medical needs”.

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Strict Regulatory Affairs Means EU Could Lose Out to US

Wednesday, July 6th, 2011

Stricter regulatory affairs are making it harder for new pharmaceuticals to gain approval, cslrecruitment.com reports.

There has been a significant decline in the amount of new drugs being approved over the previous two decades. Many new products fail at the phase III clinical trials, with 55 products failing at this stage in 2010. Chris Stirling, head of pharmaceuticals at KPMG, believes this would not have been the case just fifteen years ago.

Whilst this shows an improvement in drug standards, it also worries pharmaceutical bosses, concerned about the amount of drugs they can successfully produce with the new, tighter guidelines.

Added to this the length of time it takes EU to ratify new drugs compared to the US, making it possible for the US to market and sell drugs sooner than EU businesses, there is significant disquiet amongst EU companies that they could lose out financially.

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Looking for a Job in Regulatory Affairs? Join our Linkedin Group Today!

Monday, January 24th, 2011

Are you looking for a new position in Regulatory Affairs? Join CK’s specialist Regulatory Affairs Network on Linkedin!

CK Regulatory, part of CK Clinical, are specialists in Regulatory Affairs recruitment. We have recently set up a dedicated Linkedin group for  jobseekers looking for work in Regulatory Affairs.

CK will be utilising this group in order to provide our members with the most up-to-date job opportunities, careers advice and industry news. We’ve also found that it’s a great place to network with others in the area!

We are confident that this specialist group  will be a really useful resource for you and your colleagues within Regulatory Affairs.

Click here to join CK’s specialist Regulatory Affairs Network on Linkedin!

Senior Regulatory Affairs Associate Job – Hampshire, UK

Thursday, January 13th, 2011

As Senior Regulatory Affairs Associate you will be responsible for obtaining licences for new products and maintaining licences for existing products as well as the compilation and submission of clinical trial applications.

 

Main responsibilities:

  • Obtaining and maintaining product licences by filing submissions to regulatory agencies.
  • Provide answers to regulatory queries from the authorities.
  • Provide regulatory input to and compiling clinical trial applications, end of trial notifications and other relevant documents.
  • Using and updating corporate regulatory system database as required.
  • Build strong relationships with junior and intermediate staff in the local regulatory agency.
  • Provide excellent problem solving skills to complex issues.
  • Develop, update and implement SOPs are required.
  • Support Regional Regulatory Scientist for key assets.

 

Person Specification:

  • Life sciences degree.
  • Experience within pharmaceutical regulatory affairs.
  • Experience of compiling and submitting CTAs.
  • Knowledge of licence renewals and variations.
  • Excellent communication skills.
  • Ability to prioritise workload.

 

Apply Now

For more information or to apply for this Senior Regulatory Affairs Associate position, please contact Meera Pattni on 01438 743 047 or email mpattni@ckregulatory.com.

 

Alternatively, click here to apply for this Senior Regulatory Affairs Associate role online now.

CK Science and CK Clinical…The Perfect Merger

Tuesday, November 2nd, 2010

CK Science and CK Clinical…The Perfect MergerWe are proud to announce that as of 1st November 2010, the two specialist recruitment consultancies, CK Science and CK Clinical and will be merging and will now be known as the CK Group.


We hope you will agree that this is great news for both clients and candidates alike. As the newly formed CK Group, we aim to deliver a world class recruitment service in a socially responsible and fun way. At the core of this will be our main company values of honesty, integrity and transparency.

Here at CK, we are extremely proud to have such a rich pool of internal talent that will continue to provide you with an even more polished specialist recruitment service. In fact, one of the key reasons for the merger was to make the best use of the skills of our senior management team and to offer further training to staff. As a result, we will be continuously building on our existing strengths whilst helping to develop areas in which we as a company can improve, thus ultimately provide you with the best recruitment service possible.

Speaking of the merger of CK Clinical and CK Science, newly appointed Managing Director, Jonathan Hart-Smith stated,

“The combination of CK Science and CK Clinical as the CK Associates Group is extremely good news for our customers and the candidates we help.

“This merger creates a powerful leader in the niche recruitment industry sector, with greatly expanded areas of recruitment and a wider client and candidate base.  This means clients only have to come to one place and candidates have twice as many job opportunities available to them from one company.

“I am genuinely excited when I say that this is a great opportunity for our clients both old and new to receive a consistent quality service from the one company and the CK brand.”

Please note, that as a result of the merger, CK Science and CK Clinical will retain these trading names and the group will be known as the CK Group. The corporate entity will retain the CK Associates Ltd name.

About CK Science

CK Science was founded in 1991 by Ashley Kirk and Liam O’Connell and specialises in the recruitment of permanent and contract scientific and engineering staff for the chemical, environmental, pharmaceutical and biotechnology fields.

About CK Clinical

CK Clinical was founded in 2005 by Liam O’Connell, Ashley Kirk and Jonathan-Hartsmith. CK Clinical was founded to recruit any clinical discipline from Phase I to Phase IV and post marketed trials. The company has quickly grown to be one of the leading suppliers of clinical staff within the pharmaceutical sector.

Want to find out more? Contact Jonathan Hart-Smith on 01438 743 047 or email jhartsmith@ckclinical.co.uk.

Senior Regulatory Director (Emerging Markets) – Hertfordshire, UK

Thursday, August 12th, 2010

A Senior Regulatory Director is required to join a global pharmaceutical company based in Hertfordshire, UK.

As Senior Regulatory Director, the main purpose of your role will include:

  • To effectively manage, train and develop direct reports and others involved in the emerging markets team.
  • To ensure regulatory strategies and contributions to all projects are delivered in a timely manner to agreed costs.
  • Ensure regulatory compliance strategies are adhered to.

The main responsibilities of this Senior Regulatory Director job will include:

  • Provide oversight of all in country registrations and maintenance activities for the emerging markets territories.
  • Take responsibility for all regulatory planning and strategic activities for the target countries.
  • Oversee all teams and personnel responsible for China, Canada, Europe and Eastern Asia.
  • Directing pricing strategies, and market penetration practices.
  • Strategically supporting commercial products from a marketing stand point.
  • Take part in external initiatives to influence the development of regulatory environments.
  • Developing and guiding the global regulatory strategy.

The ideal candidate for this Senior Regulatory Director job will have experience both within the emerging markets division and also of submissions in Canada, China, UK and Asian markets.

Apply Now

For more information, or to apply for this Senior Regulatory Director role, please contact Meera Pattni on Tel: +44 (0)1438 743047 or email mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this Senior Regulatory Director role online now.

Director of Regulatory Affairs – Berkshire, UK

Wednesday, July 21st, 2010

Our client, a global pharmaceutical company based in Berkshire, is currently looking for a Director of Regulatory Affairs to join their team.

As the Director of Regulatory Affairs you will provide European regulatory guidance and strategy to your regulatory colleagues and global project teams leading to sound scientific development programs and successful registration for new biological compounds and new indications.

This Director of Regulatory Affairs role will also include the following key responsibilities:

  • You will liaise, negotiate and partner with European Regulatory Agencies. Represent the company during Agency (National/EMA) interactions
  • Schedule and lead meetings with Agencies and prepare company personnel for Agency interactions.
  • Determine the content for the Quality related section of regulatory submissions as well as evaluate submissions for accuracy.
  • You will also prepare regulatory responses to requests from health authorities and meet aggressive deadlines to ensure that regulatory Agencies receive timely and scientifically robust submissions, shortening the review process and leading to successful approval of biological products for the company’s growth thereby accomplishing corporate goals.

 

What makes this Director of Regulatory Affairs role different?

Our Client is truly a leader in its field. You can expect a smaller company feel providing you with room to grow and influence others but with the financial backing and security of an established corporate organisation. If you want to not only make a difference to the end users and patients but also help shape the way that the European Regulatory department function then this is an ideal opportunity. It will give you strategic and operational input and responsibilities.

 

Apply now

For more information, or to apply for this Director of Regulatory Affairs position, please contact Jonathan Hart-Smith on 01438 743047 or email: jhartsmith@ckclinical.co.uk.

Regulatory Publisher – Hatfield, UK

Monday, April 12th, 2010

Regulatory Publisher based in Hatfield, Hertfordshire, UK.

As Regulatory Publisher you will primarily be responsible for publishing eCTD sequences for centralised, MRP, DCP submissions. Reporting to the Senior Manager of Global Regulatory Operations, you will be expected to self manage each project by working closely with regulatory, clinical and CMC leads wherever necessary.  Working as Regulatory Publisher you will also be expected to support major submissions publishing project by assisting in formatting of word documents, bookmarking, hyperlinking and QC when necessary.

Key responsibilities of this Regulatory Publisher role will include:

  • Publish eCTD sequences for centralised, MRP and DCP submissions.
  • Updates and issues communicated during management meetings.
  • Support Major Submissions Publishing projects.

The successful candidate for this Regulatory Publisher job will have previous experience of publishing eCTD sequences. In addition, the following skills and competencies are also essential for this Regulatory Publisher role:

  • Excellent verbal and written communication skills.
  • Ability to gather necessary information when required for assigned eCTD life cycle projects.
  • Ensure lifecycle and publishing projects are processed in accordance with agency guidelines and SOPs.
  • Understanding of lifecycle management.
  • Ability to present information in a clear and concise manner.
  • Knowledge of ICH regulations and guidelines.

 

How to Apply for this Regulatory Publisher Job:

For more information, or to apply for this Regulatory Publisher job, please contact Meera Pattni on +44 (0)1438 743047 or email mpattni@ckclinical.co.uk/

 

Alternatively, click here to apply for this Regulatory Publisher job now.

 

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