Posts Tagged ‘pharmaceutical recruitment’

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.

Looking for a job in regulatory affairs? Start by clicking here, now

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.

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 Affairs Manager – Animal Health – Surrey, UK

Friday, May 28th, 2010

A Regulatory Affairs Manager is required to join one of the largest pharmaceutical companies in the world at their site based in Hertfordshire, UK.

Reporting to the Head of Regulatory Affairs, the main roles and responsibilities of this Regulatory Affairs Manager job will include:

  • Maintenance of national product MAAs for the company.
  • Work with global colleagues to ensure maintenance of globally supported products.
  • Work closely with the Quality and Manufacturing team about regulatory issues affecting maintenance of licences and new product registration.
  • Work closely with the R&D team to ensure new products are developed in a timely fashion in accordance with regulatory guidelines.
  • Advice and support other departments on regulatory issues.
  • Review promotional material for compliance with regulatory guidelines.

The ideal candidate for this Regulatory Affairs Manager job will be educated to degree level or preferably PhD level in veterinary medicine or sciences.  This Regulatory Affairs Manager job also demands a candidate with three years of Regulatory Affairs experience, ideally with a background in biological veterinary medicinal products.

 

Apply Now

For more information, or to apply for this Regulatory Affairs Manager job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this Regulator y Affairs Manager job online now.

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

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.

 

CKRegulatory- Regulatory Affairs Recruitment, Regulatory Affairs Jobs CK Regulatory - Regulatory Affairs Recruitment - Join on LinkedinCK Regulatory - Regulatory Affairs Recruitment - Follow on Twitter

Senior Regulatory Affairs Manager – Nephrology and Inflammation, based in Cambridge and Uxbridge, UK

Monday, March 15th, 2010

Our client, a leading biotechnology company, is currently looking for an experienced Senior Regulatory Affairs Manager to join their Nephrology and Inflammation Therapeutic Area.

As a Senior Regulatory Affairs manager, your role will be to develop and implement regulatory strategies to expedite global drug development and registration and to manage the execution of regional strategies and regulatory communications and submissions. You will assist in providing expertise on regional regulatory requirements and precedence to interdepartmental teams.

Further key activities of this Senior Regulatory Affairs Manager job will include:

  • Participate through the Global Regulatory Team in the development of product label and core data sheet.
  • Respond to requests from the Global development team and functional areas.
  • Advocate and actively support regulatory compliance.
  • Help to develop regional regulatory strategy for integration into the Global Regulatory Plan.
  • Develop TA expertise.
  • Help resolve any problems on the critical path to regional registration in concert with global registration strategy.

The ideal candidate for this Senior Regulatory Affairs Manager job will be qualified to a minimum Bachelors degree. You will have in-depth experience of Regulatory Affairs Research Development or related area in the Biotech/Pharmaceutical industry, along with experience in inflammation, drug development and CMC knowledge. Line management experience is also desirable.

How to Apply

If you would like to hear more about this Senior Regulatory Affairs Manager job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this Senior Regulatory Affairs Manager job now.

 

About CK Regulatory

CK Regulatory is a specialist Recruitment company offering job opportunities to Regulatory Affairs professionals seeking work in Pharma, Biotechnology, Medical Devices and Regulatory Consultancies. As part of CK Clinical we have an established and enviable track record of providing a high quality recruitment service to Pharmaceutical professionals.

Regaffairsjob.comnlinkedintwitter

Regulatory Affairs Manager (Emerging Markets), based in Uxbridge, UK

Thursday, March 11th, 2010

Our client, a pioneering biotechnology company, is currently looking for a Regulatory Affairs Manager to join their team based in Uxbridge, UK.

As a Regulatory Affairs Manager, you will be responsible for:

  • Using your knowledge of internal regulatory affairs to provide input into product strategy for the IE region.
  • Preparing internal market applications for new products.
  • Reviewing post market variations.
  • Liaise with CMC and help support the execution of labelling variations within the region.
  • Keep the IE project lead informed of all developments to do with the life cycle activity.
  • Provide advice and support on regional regulatory mechanisms to optimise product registration.
  • Contribute to product strategy.
  • Track status of MAA, variations, submissions and approvals.
  • Lead preparation of responses to questions raised by regulatory authorities.

The ideal candidate for this Regulatory Affairs Manager job will be educated to minimum Bachelors degree or will have equivalent education/experience. A Masters or Doctorial degree would be advantageous.

How to Apply

In order to register your interest in this Regulatory Affairs Manager job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this Regulatory Affairs Manager job now: http://ckclinical.co.uk/job/Regulatory-Affairs-Manager/ebb03e1fOVJO

 

About CK Regulatory

CK Regulatory is a specialist Recruitment company offering job opportunities to Regulatory Affairs professionals seeking work in Pharma, Biotechnology, Medical Devices and Regulatory Consultancies. As part of CK Clinical we have an established and enviable track record of providing a high quality recruitment service to Pharmaceutical professionals.

CKRegulatory1twitterlinkedin

EU Regulatory Strategist Required for Wordwide Pharmaceutical Company based in the South of England

Tuesday, February 23rd, 2010

Our client, one of the world’s leading pharmaceutical companies is currently looking for an EU Regulatory Strategist to join their team based in the South of England.

Reporting to the EU Regulatory Strategy Portfolio Manager, your role will include:

  • Ensuring EU contribution to Global Regulatory Strategies and implementation plans.
  • Ensuring that the regulatory contributions work towards achieving the objectives in the strategy.
  • Be responsible for providing the required regulatory contributions to project teams, adhering to time and cost deadlines.
  • To liaise with Senior Management regarding regulatory plans.
  • Work closely with the Regulatory Product manager to ensure consistent and appropriate process, working practices and quality standards.

The ideal candidate for this EU Regulatory Strategist role will be educated to a minimum degree level in a scientific subject and will have demonstrable have experience of the following:

  • EU regulations.
  • CTA and MAA submissions process.
  • Management of complex regulatory issues.

If you would like to hear more about this EU Regulatory Strategist job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this EU Regulatory Strategist job

Click here to apply for other Regulatory Affairs jobs.

 

About CK Regulatory

CK Regulatory is a specialist Recruitment company offering job opportunities to Regulatory Affairs professionals seeking work in Pharma, Biotechnology, Medical Devices and Regulatory Consultancies. As part of CK Clinical we have an established and enviable track record of providing a high quality recruitment service to Pharmaceutical professionals.

ckrLogo linkedintwitter