Posts Tagged ‘Regulatory Affairs’
Tuesday, July 19th, 2011
Nektar has been given a positive review of its ovarian cancer drug, reports the Pharmaceutical Business Review.
The Committee for Orphan Medicinal Products, a branch of the European Medical Association, has responded positively in relation to Nektar’s attempt to have its ovarian cancer drug granted orphan medicinal product status, which can lead to extended exclusivity. A phase II study is currently recruiting patients with ovarian cancer, whilst the company are looking to begin a phase III study later this year.
Nektar Drug Development and Regulatory Affairs vice president Carlo DiFonzo has said that the news of the positive opinion is welcome following the recent designation of orphan drug status in the US in April.
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Tags: CK Clinical, ck regulatory, ck science, ema, european medical association, Jobs for regulatory affairs, jobs in regulatory affairs, nektar, pharma regulatory affairs jobs, Regulatory Affairs, Regulatory Affairs Jobs, Regulatory affairs jobs in uk
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Monday, July 18th, 2011
Meera at CK Regulatory, is currently looking for a Regulatory Affairs Project Manager to join a Development Partnering Organisation to join their European office which is based in Central London.
The company:
This Development Partnering Organisation act as virtual partners in supporting its Biotechnology and Pharmaceutical clients throughout the entire clinical research, development and submission process.
The role:
The main responsibilities of this Regulatory Affairs Project Manager position include:
- Conducting regulatory reviews of technical summaries, clinical study reports and administrative documents forregulatory filings.
- Assisting with the filings and approval processes for MAA products within all types of European procedures.
- Assisting with regulatory submissions outside of EU authorities including Switzerland, South Africa and Australia.
- Assisting with providing regulatory expertise on MA life cycle management – variations, renewals, labelling and line extensions.
- Ensuring submissions adhere to EU and ICH guidelines.
- Ensuring submission process and standards adhere to internal SOPs.
- Interacting with clients regarding regulatory issues.
- Conducting regulatory reviews for eCTD/electronic submission requirements.
The candidate:
The ideal candidate for this Regulatory Affairs Project Manager position will have the following skills, qualifications and experience:
- Minimum of a Bachelors degree in life sciences.
- Previous experience with regulatory submissions in the EU.
- Experience with eCTD.
- Proficiency in performing document reviews and quality assurance checks.
- Ability to manage multiple projects simultaneously.
- Prior experience communicating with external clients.
- Experience with Medical Devices combined with either drug or biologics preferable.
Apply now
For more information or to apply for this Regulatory Affairs Project Manager position, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com Please quote reference CL22236 in all correspondence.
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Friday, July 15th, 2011
A global pharmaceutical company are currently looking for a Regulatory Affairs Director to join their team based in Hertfordshire, UK.
The job
As Regulatory Affairs Director, you will be representing Regulatory Affairs as the Global Regulatory lead on international project teams ass well as leading the global regulatory sub-team. The role also involves providing regulatory Strategy and submission support to help drive the full drug development process. In addition, another key responsibility of this Regulatory Affairs Director position will be to lead major MAA projects and liaise closely with health authorities for the approval of products with optimal labelling.
Your responsibilities:
As Regulatory Affairs Director at this successful and established pharmaceutical company, your responsibilities will also include:
- Directing regulatory strategy and contributing to its outcome for assigned projects.
- Providing input into the project’s objective setting, maintaining an accurate and efficient tracking system.
- Leading regulatory affairs sub team and creating Global Regulatory Affairs Strategic Plan.
- Coordinate global submission activities, lead global/regional submission activities:
- Ensuring that filing strategy, regulatory submission and meetings with regulatory authorities globally aligned.
- Leading a cross functional team plan, prepare and complete major submissions.
- Providing strategic input into product lifecycle plans and maintain licences for marketed products.
- Becoming the day to day contact point with regulatory authorities for communications relating to assigned projects.
- Managing and coordinating requests for scientific advice with regulatory agencies.
- Assisting with the creation and review of SOPs.
You
The successful candidate for this Regulatory Affairs Director position will have the following qualifications, experience and skills:
- Life sciences degree.
- Good knowledge of the global regulatory environment.
- Ability to direct regulatory strategy and contribute to its outcome when necessary.
- Strong EU regulatory experience and a good understanding of US regulatory processes.
- Oncology therapeutic area experience highly desirable.
- Extensive submissions experience.
- Excellent leadership and people management skills.
- Ability to manage multiple projects and tasks.
Apply now
For more information or to apply for this Regulatory Affairs Director role, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckclinical.co.uk. Please quote reference CL22281 in all correspondence.
Tags: EU regulatory affairs, global regulatory affairs, Jobs for regulatory affairs, jobs in regulatory affairs, jobs regulatory affairs, lifecycle management, pharma regulatory affairs jobs, Regulatory Affairs, Regulatory Affairs Director Job (Oncology) – Hertfordshire, regulatory affairs director job description, regulatory affairs director job London, regulatory affairs director jobs, regulatory affairs director recruitment uk, Regulatory affairs jobs in uk, Regulatory affairs oncology, regulatory affairs oncology jobs, regulatory authorities, regulatory strategy, uk
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Thursday, July 14th, 2011
CK Regulatory has recently launched a new Facebook page for people to stay up to date on all that’s happening in the world of Regulatory Affairs.
If you’re looking to start a career, or looking for someone to fill a role withing your company, then the CK team can help as we have access to some of the best Regulatory jobs in the industry, an enviable track record of providing high quality recruitment to pharmaceutical companies and we aim to make the job hunting process as easy and enjoyable as possible for both clients and candidates.
For regular updates, make sure to ‘like’ us here
Tags: ck regulatory, ck science, ckregulatory, jobs in regulatory affairs, pharma jobs uk, pharma recruitment uk, Regulatory Affairs, Regulatory Affairs recruitment, regulatory affairs recruitment agency uk, regulatory affairs recruitment uk
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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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Tags: CK Clinical, ck regulatory, ema, european medical association, novartis, pharmaceutical jobs, Regulatory Affairs, regulatory affairs jobs uk, regulatory affairs recruitment uk, Regulatory affairs uk, regulatory affaris recruitment, rehulatory affairs jobs
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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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Tags: ck regulatory, EU, kpmg, pharma, pharma jobs, pharma jobs uk, pharmaceutical jobs, pharmaceutical jobs uk, pharmaceuticals, Regulatory Affairs, Regulatory Affairs Jobs, regulatory affairs jobs uk, Regulatory Affairs recruitment, regulatory affairs recruitment uk, us
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Tuesday, July 5th, 2011
The increased demand by medicine regulators on license holders has led to increased importance being placed on regulatory affairs, reports inpharm.com. Areas such as paediatric requirements and pharmacovigilance have grown over the last decade, and as the science behind medicine evolves, there needs to be people who can understand and manage what is happening.
Lynda Wright, executive director at The Organisation for Professionals in Regulatory Affairs (TOPRA), says that information has to be effectively processed and assimilated, meaning that “you have to be a confident scientist and say, yes, I can get my head around all that information.” Whereas previously regulatory affairs staff were drawn from pharmacy, an increase in biomedical degrees has led to many others becoming involved in RA.
TOPRA is attempting to increase the amount of students joining straight from university, as traditionally it has been necessary to have experience in the RA field. By working with universities and arranging internships, it hopes to help students looking to go into RA.
Lynda Wright also comments that, whilst RA is not free from cuts, those who are found out of work “are not for long” and mentions that those found redundant in other areas of the pharmaceutical industry could find work within regulatory affairs.
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Tags: biomedical, cka group, ckregulatory, inpharm.com, Jobs, lynda wright, medical affairs, pharmaconvigilance, Regulatory Affairs, Regulatory Affairs Jobs, regulatory affairs jobs uk, regulatory director, regulatory executive, regulatory manager, TOPRA
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Tuesday, June 14th, 2011
My client is a regulatory consultancy based in Essex. They are committed to resolving any regulatory, pharmacovigilance, patient information leaflet testing and quality issues within Europe. They are now looking to take on a Regulatory Affairs Senior Manager with a proven expertise in CMC.
Responsibilities:
- Preparation, compilation, review and submission of regulatory documentation.
- Handle both pre and post marketing activities on behalf of the client including CTAs, National, Mutual Recognition and Centralised Applications.
- Attend and guide clients through regulatory authority meetings.
- Provide regulatory advice and support to clients throughout product development.
- Report writing and investigations related to client projects.
- Maintain adequate paper and electronic filing systems.
- Dossier and development gap analysis.
- Project management.
Person specification:
The ideal candidate for this Regulatory Affairs Senior Manager position will have the following skills and experience:
- Extensive experience within pharmaceutical regulatory affairs.
- Demonstrable experience specifically within CMC.
- Excellent knowledge of EU regulations.
- Excellent interpersonal skills.
- Project management experience.
- Excellent interpersonal skills.
- Ability to thrive under pressure and prioritise workload.
Apply now
For more information or to apply for this Regulatory Affairs Senior Manager position, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com. Please quote reference CL22142 in all correspondence.
Tags: EU regulatory affairs, pharmaceutical regulatory affairs recruitment uk, pharmaceutical regulatory affairs uk, post marketing, pre marketing regulatory affairs, project management, Regulatory Affairs, regulatory affairs jobs uk, regulatory affairs recruitment uk, regulatory CMC
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Tuesday, June 7th, 2011
My client is a privately owned research and development company specialising in respiratory medicines. They are now looking to take on a Regulatory Affairs Manager to deal with life cycle management activities.
As Regulatory Affairs Manager, you will be required to apply for and maintain product licences held by the company, ensuring they are kept up to date and keeping in contact with the relevant regulatory authorities.
Main responsibilities:
As Regulatory Affairs Manager, your main responsibilities will include:
- Preparation and submission of applications, renewals and variations to the relevant authorities, in a timely and accurate manner.
- Follow up with regulatory authorities on submissions and regulatory issues.
- Request, review and submit all PSURs.
- Direct negotiations and liaisons with third party companies, and other departments of the company concerning submission applications.
- Writing, reviewing and advising on SmPCs and packaging.
- Keep up to date with the latest guidelines and legislation.
- Responsible for the management of the Regulatory Affairs Administrator and Regulatory Affairs Executive.
- Responsible for training and career development of the team through setting objectives and performance review processes.
Person specification:
The ideal candidate for this Regulatory Affairs Manager position will have the following skills and experience:
- Experience working with products distributed in the UK.
- Experience of PSURs, lifecycle maintenance and variations.
- Experience managing individuals beneficial.
- Life sciences degree essential.
- Commercial acumen beneficial.
How to apply
For more information or to apply for this Regulatory Affairs Manager job, please contact Meera Pattni at CK Regulatory on 01438 870024 or mpattni@ckregulatory.com. Please quote reference CL21969 in all correspondence.
Tags: lifecycle management, MHRA, PSURs, reg affairs jobs Cheshire, Regulatory Affairs, Regulatory Affairs Jobs, regulatory affairs jobs Cheshire uk, Regulatory Affairs Manager, regulatory affairs manager job description, regulatory affairs manager jobs cheshire, regulatory affairs manager jobs uk, regulatory affairs manager uk, regulatory affairs recruitment uk, Regulatory affairs uk, regulatory variations
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Friday, May 27th, 2011
Job purpose:
As Regulatory Associate, you will be required to assist the Regulatory Manager in determining the regulatory strategy for assigned products, and maintain marketing authorisations throughout the world.
Main responsibilities:
As Regulatory Manager, your main responsibilities will include:
- Work collaboratively with the Regulatory Manager to implement regulatory strategy.
- Work with colleagues to define global registration dossiers.
- Assist in monitoring, collecting and sharing and regulatory issuesand trends that will impact the company and their products and policies. Assist in developing strategies to address them.
- Advise R&D personnel on data requirements for any variations necessary to maintain compliance.
- Advise other colleagues on regulatory, safety and labelling related issues.
- Assist in the preparation of responses to questions from regulatory authorities.
- Provide technical support to respond to consumer and legal enquiries concerning technical, safety and regulatory issues.
Person specification:
To be considered for this Regulatory Associate position, you must have the following qualifications, skills and experience:
- Life sciences degree is essential.
- Experience within a laboratory or regulatory affairs environment is essential.
- The business language is English, therefore fluency in English is essential.
- Strong negotiating and interpersonal skills.
- Understanding of marketing strategy and planning issues.
- Openness to change.
How to apply
For more information or to apply for this Regulatory Associate job, please contact Meera Pattni at CK Regulatory on 01438 870024 or email mpattni@ckregulatory.com.Please quote reference CL22044 in all correspondence.
Tags: ck regulatory, health and personal care, marketing authorisation applications, meera pattni, Regulatory Affairs, regulatory affairs careers uk, regulatory affairs jobs uk, regulatory affairs recruitment agencies uk, regulatory affairs recruitment uk, regulatory compliance, regulatory HPC, regulatory strategy
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