Posts Tagged ‘Regulatory Affairs recruitment’
Tuesday, October 11th, 2011
Meera Pattni at CK Regulatory is currently recruiting for an Associate Director of Regulatory Affairs to be based in the North West of England.
Responsibilities:
- Direct and prepare regulatory submissions as required for global approvals for IVDs, including preparation of reports and interaction with regulatory officials.
- Review product labelling and promotional literature for regulatory compliance.
- Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with global regulatory agencies.
- Liaise with regulatory agencies for enquiries and issues.
- Review R&D protocols and technical reports and other company documents for use in regulatory submissions and in response to questions from regulatory authorities.
- Oversee and direct the preparation of regulatory documentation for country specific registrations.
- Develop regulatory SOPs relevant for registration of IVD products or other regulatory aspects.
Person specification:
- Extensive experience in the medical device industry, preferably with IVD experience and extensive regulatory affairs experience.
- Experience in the preparation and submission of 510K, PMAs, IND, CE Design Dossiers, CE Technical Files.
- Possess a working knowledge of MDD and IVDD, applicable ISO standards.
- Ability to work as part of a team.
- Excellent influencing and negotiating skills.
- Excellent verbal and written communication skills.
How to apply:
For more information or to apply for this Associate Director of Regulatory Affairs position, please contact Meera on 01438 870024 or email a copy of your CV to mpattni@ckregulatory.com. Please quote reference CL22924 in all correspondence.
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Monday, October 3rd, 2011
Meera Pattni at CK Clinical is recruiting for a Global Regulatory Affairs CMC Associate to join a successful and innovative pharmaceutical company at their site in Yorkshire, UK.
The job:
As Global Regulatory Affairs CMC Associate, you will be required to assist the new product development and existing product development projects within the scope of the global regulatory CMC team. You will also assist and support regulatory CMC strategy and deliver submissions.
Responsibilities:
- Deliver global regulatory affairs CMC project activities by effective coordinator, strategy and implementation.
- Prepare and deliver regulatory submissions including CTAs, MAAs, INDs and variations/renewals in line with defined CMC plans.
- Work collaboratively with appropriate company personnel and contractors to coordinate the regulatory work stream elements for CMC activities.
- Liaise with regulatory authorities as required.
- Maintain documented regulatory project plans in line with best practice recommendations.
- Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the CMC team.
The ideal candidate:
Meera is looking for candidates will the following skills:
- Excellent communication skills.
- Highly organised.
- Ability to handle multiple projects at once.
- Results orientated.
- Strong negotiating and interpersonal skills.
- Openness to change.
How to apply:
For more information or to apply, please contact Meera on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL22877 in all correspondence.
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Friday, September 2nd, 2011
Pharmaceutical-business-review.com has reported that French pharmaceutical company Roche has received approval from the European Commission (EC) for lung cancer drug Tarceva.
The drug can now be used as a treatment on it’s own to treat patients with locally advanced or metastatic lung cancer. Prior studies have shown that Tarceva nearly doubles the amount of time patients survive without their cancer progressing when compared to chemotherapy.
Hal Barron, Roche’s head of Global Product Development and chief medical officer believes the European approval to be good news for those with genetically distinct forms of the cancer because they can receive a greater benefit when the medicine is used as an initial treatment.
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Tags: CK Clinical, ck regulatory, ck science, Clinical jobs, clinical recruitment, EU, European Commission, European Regulatory Affairs, jobs in reg affairs, jobs in regulatory affairs, Reg Affairs Jobs, Reg Affairs Recruitment, Regulatory Affairs Jobs, Regulatory Affairs recruitment, Roche, uk
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Tuesday, August 30th, 2011
Meera Pattni at CK Regulatory is recruiting for a Senior Regulatory Engineer to be based in the Netherlands.
The Company
Meera’s client is a global marketer of consumer and commercial products that develop innovative products and system solutions in the categories of food service, cleaning, safety, material handling, refuse and agriculture amongst others.
The Job
As Senior Regulatory Engineer, you will be responsible for coordinating and auctioning activities within regulatory affairs to ensure that all manufactured products and services provided by the company meet the quality requirements of the company, regulatory and notified bodies.
Responsibilities:
- Manage the regulatory affairs area to ensure that objectives are implemented in line with overall quality/corporate goals.
- Ensure compliance with local regulatory agencies and establish relationships with outside testing facilities as required.
- Provide update regarding regulatory status and requirements of company products. Ensure customers receive regulatory and certification information in a timely manner.
- Compile device master records, technical files, design dossiers, FDA and European submission documents that meet regulatory requirements.
- Ensure staff understand and comply with the requirements of cGMP as applied to the company products.
- Review Change Control requests, deviation requests, quality system reports for adequacy and compliance with company and regulatory requirements.
- Participate in the development and maintenance of the Company’s Quality System to meet the requirements of the US FDA and other applicable quality and regulatory standards.
You:
The ideal candidate for this Senior Regulatory Engineer will have the following skills and experience:
- Degree in a science or quality related subject.
- Previous experience in a quality or regulatory affairs role essential.
- Experience in the development and management of regulatory submissions and documents.
- Experience with internal and external audit processes.
- Demonstrated expertise in cGMPs, FDA regulations, SOP development.
Apply now:
For more information or to apply online for this Senior Regulatory Engineer position, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com. Please quote reference CL22593 in all correspondence.
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Friday, August 26th, 2011
Meera Pattni at CK Regulatory is currently helping a number of excellent Regulatory Affairs candidates looking for both permenant and contract positions. Please see below to find out more:
Junior Regulatory Professional
Meera is currently helping this Junior Regulatory Professional to find a new position.
This excellent candidate has recently completed a Masters in Clinical Research and has experience in:
- Preparing registration documents for marketing approval
- Drafting MHRA submissions for device approvals
Open to both permanent and contract positions, this candidate is available at short notice.
Regulatory Consultant
Meera Pattni at CK Regulatory is currently helping a Regulatory Consultant to find a new contract role close to the M4 corridor.
This candidate has experience in the following:
- Life cycle management on marketed products within neurology, oncology and haematology.
- Coordinating preparation for Scientific Advice Meetings with Regulatory Agencies in Europe.
- Developing regulatory strategies for development and marketed products.
- Contributing on regulatory aspects of Risk Management Plan.
Senior Regulatory Operations Professional
Meera at CK Regulatory is currently helping a Senior Regulatory Operations Professional to find a new permanent or contract role.
Available immediately, this candidate has experience in:
- Providing strategic submission intelligence to colleagues.
- Ensuring submissions meet EU, FDA and ICH guidelines.
Medical Devices Regulatory Specialist
Meera Pattni at CK Regulatory is helping a Medical Devices Regulatory Specialist to find a new role in the South East.
This candidate has excellent experience in:
- Generating technical dossiers to meet global regulatory requirements for markets including FDA, Japan, Brazil and Europe.
- Internal auditing.
- Working with Class I, IIa and IIb medical devices.
- Generating local department quality systems procedures.
For more information regarding any of the candidates detailed above, please contact Meera Patti at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com.
Tags: ck regulatory, junior regulatory professional, medical devices regulatory specialist, meera pattni, regulatory affairs candidates, Regulatory Affairs Jobs, Regulatory Affairs recruitment, regulatory associate, Regulatory Consultant
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Tuesday, August 23rd, 2011
Meera Pattni is currently helping a global pharma company to recruit for a Junior Global Regulatory Program Manager to join their team based in Basel.
Job purpose:
You will work under some supervision to provide support to the Senior Global Regulatory Program Manager for programs through development, registration, approval/post approval. Based the global regulatory strategy, you will implement global regulatory plans for their assigned regions and assist with compliance activities.
Main responsibilities:
Regulatory Strategy:
- Support arrangements of the Company’s regulatory advisory board on regulatory strategy.
- Contribute to the plans for global regulatory readiness with other line functions.
- Serve as the drug regulatory affairs representative on product sub teams.
Health Authority interactions:
- Implement plans for HA interactions as determined by the Senior GRPM.
- Coordinate responses to HA requests.
- Coordinate rehearsals to HA meetings.
Submissions and Approvals:
- Assist with the preparation, QC and submission of worldwide dossiers and maintenance submissions.
- Ensure timely availability of supporting documents.
- Collaborate on the development and implementation of plans to avoid/minimise clock stops during submission.
- Coordinate regulatory activities and submit CTA and INDs with supervision.
Prescribing information:
- Coordinate the regulatory strategic input provided on the prescribing information.
- Revise labels as needed to achieve timely health authority approval.
Regional Excellence and Compliance:
- Prepare annual reports and renewals and ensure on time submissions to health authorities.
- Enter product specific attributes as provided by the Senior GRPM in to compliance database.
- Provide support as needed for non project related regional excellence activities.
Promotional/Non-Promotional Review:
- Assist in the review of promotional and non-promotional materials and press releases as required and work with the GRPD to ensure messages are consistent with the Company’s policies and guidelines.
The ideal candidate:
To be considered for this position, you will have the following skills, experience and qualifications:
- Previous experience within pharmaceutical regulatory affairs.
- Life sciences degree essential.
- Awareness of the drug development process.
- Good communication and negotiation skills.
- Ability to work in cross functional teams.
- Ability to work as part of a team.
How to apply:
For more information or to apply for this Junior Global Regulatory Program Manager please contact Meera Pattni on 01438 743 047 or email mpattni@ckregulatory.com. Please quote reference CL22640 in all correspondence.
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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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Tags: CK Clinical, ck regulatory, ck science, glaxosmithkline, GSK, impax pharmaceuticals, parkinsons, pharma jobs, pharma recruitment, pharmaceutical jobs, pharmaceutical recruitment, Regulatory Affairs Jobs, Regulatory Affairs recruitment, science jobs, science recruitment, uk
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Monday, August 8th, 2011
Meera Pattni at CK Regulatory is looking for a Regulatory Affairs Therapy Area Head to join a large Pharmaceutical company based in Berkshire.
The role:
As Regulatory Affairs Therapy Area Head, you will work within Immunology, Virology, Neonataology and Oncology. CNS/Pain groups. Your main responsibilities will include:
- You will be responsible for setting and implementing regulatory strategy for the assigned therapeutic area.
- Represent Regulatory Affairs on Brand Teams.
- Lead and support regulatory personnel in the affiliate groups, through ongoing communication and development, as well as training and mentoring of local Regulatory Leaders.
The ideal candidate:
To be considered for this position, you will have the following skills, qualifications and experience:
- Previous experience in a Senior level regulatory position within the pharmaceutical industry.
- Excellent understanding of the regulatory requirements for the Western Europe and Central/Eastern Europe and Russia regions.
- Existing network of regulatory authority contacts in the relevant markets.
- Excellent communication skills, knowledge of a second language would be an advantage.
- Previous experience developing regulatory strategy required.
How to apply:
For more information or to apply for this Regulatory Affairs Therapy Head, please contact Meera Pattni on 01438 743 047 or email mpattni@ckregulatory.com.
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Thursday, August 4th, 2011
Meera Pattni at CK Regulatory is currently looking for a Regulatory Affairs Manager to join a UK based pharmaceutical company with a specialist interest in dermatology.
The role:
The main responsibilities of this Regulatory Affairs Manager include:
- Preparation and implementation on a wide range of regulatory strategies for various product types.
- Preparation of documentation and coordination of scientific advice meetings.
- Compilation or review of IMPDs and CTA applications.
- Orphan applications.
- Project management of a wide range of development projects.
- Preparation and submission of UK/Irish National new applications.
- CTD conversions.
- Review wide range of project data – CMC, clinical and non clinical.
- Preparation of bibliographical applications.
- Technical due diligence for client company acquisitions.
- Preparation and delivery of training programmes on CMC data requirements and variations application procedures.
The ideal candidate:
The successful applicant will have the following skills, experience and qualifications:
- Life sciences degree.
- Extensive knowledge of regulatory requirements for new and existing products.
- Experience with all EU marketing authorisation applications, clinical trial applications and drug master files.
- Self starter.
- Ability to work independently or as part of a team.
- Project management.
How to apply:
For more information or to apply, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com.
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Friday, July 29th, 2011
Samarind RMS has been released in its fourth version by Samarind Limited, a provider of software to the regulatory affairs profession, reports PharmiWeb.com.
The new software is designed for worldwide usage rather than a solely European venture. Many companies are showing interest in the EudraVigilance Medicinal Product Dictionary software update, needed to fall in line with EMA regulations and are looking to submit their information to be included before the July 2012 deadline.
Samarind’s Phil Turner comments “Our objective remains to ensure that we align our software with the current and future needs of the regulatory affairs profession.” Samarind RMS reduces costs of managing licences and also increases profitability of said licences.
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Tags: CK Clinical, ck regulatory, ck regulatory affairs recruitment, ck science, Jobs for regulatory affairs, jobs in regulatory affairs, pharma jobs, pharma jobs uk, pharma recruitment, pharma recruitment uk, Reg Affairs Jobs, Reg Affairs Recruitment, regulatory affairs jobs uk, Regulatory Affairs recruitment, Regulatory affairs uk, research and development
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