Posts Tagged ‘Reg Affairs’
Wednesday, August 3rd, 2011
Pharmaceutical company Merck has filed to get its drug ridaforolimus a marketing authorisation from the European Medicines Agency (EMA), reports pharmaceuticalbusinessreview.com.
The drug is an mTOR inhibitor and has completed a phase III trial to be studied in various cancer indications. The drug was first conceived in 2007, when Merck and ARIAD Pharmaceuticals signed an agreement to develop and market the drug. Changes to this agreement were made in 2010, at which time Merck took over responsibility to develop, commercialise and manufacture the drug. As such, Merck is now involved in everything, including the drug’s clinical trials.
Authorisation by the EMA will mean ARIAD receives a $25 million payment from Merck, for the drug reaching projected targets. Marketing approval in the US will lead to a further $25 million for ARIAD, and a license to sell the drug in Europe will lead to ARIAD being paid another $10 million. ARIAD CEO Harvey Berger commented that his company is looking forward to the submission and additional filings of the drug.
Looking for a job in regulatory affairs? Start by clicking here, now
Tags: CK Clinical, ck regulatory, ck science, Clinical Trials, clinical trials jobs, graduate science jobs, Jobs for regulatory affairs, jobs in regulatory affairs, pharma regulatory affairs, pharmaceutical industry jobs uk, pharmaceutical jobs uk, Reg Affairs, Regulatory affairs jobs in uk, regulatory affaisr
Posted in News | No Comments »
Monday, February 28th, 2011
Our client, a leading pharmaceutical company is looking for a Senior Regulatory Affairs Executive to join their team based in Buckinghamshire, UK.
Reports to: Regulatory Affairs Manager
Job accountabilities:
As Senior Regulatory Affairs Executive, your main accountabilities will include:
- Maintenance of clinical trial and marketing authorisation applications.
- Preparing and submitting applications to the relevant authorities.
- Keep up to date with legislation’s affecting pharmaceuticals in UK and Europe.
- Preparation and maintenance of text for PILs, SPCs and more.
- Take responsibility for ensuring company promotional materials are compliant with legislation’s.
- Keep in contact and maintain a good working relationship with the MHRA and other regulatory authorities
You will have:
The ideal candidate for this Senior Regulatory Affairs Executive position will have the following:
- A good work knowledge of regulatory affairs.
- Excellent written and verbal communication skills.
- Broad experience in the pharmaceutical industry.
- Experience within marketing, research and information functions are beneficial.
Apply Now
For more information or to apply for this Senior Regulatory Affairs Executive position, please contact Meera Pattni at CK Regulatory on 01438 870024 or email mpattni@ckregulatory.com. Entitlement to work in the EEA is essential. Please quote reference CL21396 in all correspondence.
Alternatively, click here to apply for this Senior Regulatory Affairs Executive job online now.
Not quite what you’re looking for? Click here to search our Regulatory Affairs jobs online now.
Tags: Buckinghamshire, clinical trial applications, marketing authorisations, meera pattni, MHRA, Reg Affairs, Regulatory Affairs, regulatory affairs clinical, Regulatory Affairs Jobs, Regulatory Affairs recruitment, regulatory authorities, Regulatory Submissions, Senior Regulatory Affairs Executive Job, uk
Posted in Featured Job, News | No Comments »
Tuesday, November 16th, 2010
If you’re not already on Linkedin, as a jobseeker looking to find work in Regulatory Affairs, you’re missing a trick. Having a presence on Linkedin is essentially your chance to showcase your strengths, thus encouraging not only the right people, but also the right opportunities to come to you. The best way to do this is to create a great profile. Here are some tips to tips help you create a profile that will stand out from the crowd.
Once you have created your profile, why not become part of the CK Regulatory community by joining our Linkedin Group. By joining our group you will have instant access to our latest Regulatory Affairs job opportunities, industry news and careers advice. Not only this, but you will be able to keep in contact and chat with other job-seekers in your position!
Click here to join the CK Regulatory Linkedin group.
Tags: ck regulatory, Jobs, linkedin group, looking for a job in regulatory affairs, Recruitment, Reg Affairs, Regulatory Affairs Jobs, regulatory affairs jobseekers, uk
Posted in General, News | No Comments »
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.
Tags: Hertfordshire, pharmaceutical company, pharmaceutical jobs, Reg Affairs, Regulatory Affairs, Regulatory Affairs Jobs, Regulatory Affairs recruitment, Senior Regulatory Director
Posted in General, News | No Comments »
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.
Tags: Berkshire, Director of Regulatory Affairs, pharmaceutical company, pharmaceutical jobs, pharmaceutical recruitment, Reg Affairs, Regulatory Affairs Jobs, Regulatory Affairs recruitment, uk
Posted in Featured Job, News | No Comments »
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.
Tags: CK Clinical, ck regulatory, Hatfield, Hertfordshire, Herts, job, Jobs, pharma jobs, Pharmaceutical, pharmaceutical jobs, pharmaceutical recruitment, Reg Affairs, Regulatory Affairs, Regulatory Affairs Jobs, Regulatory Affairs recruitment, Regulatory Publisher, south, South East, uk
Posted in Featured Job, News | No Comments »
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.
Tags: Biotech, Biotechnology, Cambridge, Clinical, clinical recruitment, CMC, development, drug development, Inflammation, job, Nephrology, Pharmaceutical, pharmaceutical recruitment, Reg Affairs, Reg Affairs Recruitment, Regulatory Affairs, Regulatory Affairs recruitment, research, role, senior regulatory affairs manager, South East, uxbridge, vacancy
Posted in Featured Job, News | No Comments »
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.
Tags: based in Uxbridge, Biotechnology, Clinical jobs, clinical recruitment, Data Management jobs, drug safety jobs, job, Jobs, jobs in pharma, Medical information jobs, Medical writing, pharmaceutical jobs, pharmaceutical recruitment, pharmaceutical regulatory affairs, Pharmacovigilance Jobs, Reg Affairs, reg affairs job, Regulatory Affairs, Regulatory Affairs Manager, Regulatory Affairs Manager (Emerging Markets), Regulatory Affairs recruitment, uk, uxbridge
Posted in Featured Job, News | No Comments »
Tuesday, March 9th, 2010
Our client, a company which specialises in the research and development of prescription drugs, are currently looking for a Senior Regulatory Affairs Executive to be based in Buckinghamshire.
Reporting to the Regulatory Affairs Manager, your main responsibilities as a Senior Regulatory Affairs Executive will include:
- Maintenance of clinical trial and marketing authorisation applications.
- Preparing and submitting applications to the relevant authorities.
- Keep up to date with legislation’s affecting pharmaceuticals in UK and Europe.
- Preparation and maintenance of text for PILs, SPCs and more.
- Take responsibility for ensuring company promotional materials are compliant with legislation’s.
- Keep in contact and maintain a good working relationship with the MHRA and other regulatory authorities
The ideal candidate for this Senior Regulatory Affairs Executive will have the following skills and competencies:
- A good work knowledge of regulatory affairs.
- Excellent written and verbal communication skills.
- Broad experience in the pharmaceutical industry.
- Experience within marketing, research and information functions are beneficial.
How to Apply
If you would like to hear more about this Senior Regulatory Affairs Executive role, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.
Alternatively, click here to apply for this Senior Regulatory Executive job now.
If this vacancy is not exactly what you are looking for why not give us a call, we may be dealing with a vacancy better suited to your needs.
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.
Tags: Buckinghamshire, bucks, CK Clinical, ck clinical jobs, ck regulatory, Clinical jobs, clinical recruitment, job, Jobs, Medical Information, Pharmaceutical, pharmaceutical jobs, Recruitment, Reg Affairs, Regulatory Affairs, Regulatory Affairs Manager, senior regulatory affairs executive, uk
Posted in Featured Job, News | No Comments »
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.
Tags: CK Clinical, ck regulatory, Clinical jobs, clinical recruitment, communication, CTA, EU, EU regulations, EU Regulatory Strategist job, MAA, pharma, pharmaceutical company, pharmaceutical jobs, pharmaceutical recruitment, Reg Affairs, Regulatory Affairs, Regulatory Affairs recruitment, south, South East, strategies, uk
Posted in Featured Job, News | No Comments »
