Posts Tagged ‘regulatory affairs recruitment uk’
Thursday, September 20th, 2012
Here are a few of our latest Regulatory Affairs roles in the UK:
Click on the links to find out more about the roles:
Shreeya Patel is recruiting an experienced Medical Writer to join an expanding team within a pharmaceutical company at their site based in Hertfordshire.
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Shreeya Patel is recruiting an Associate Director of Regulatory Affairs and CMC to join a global pharmaceutical company based at their site in Hertfordshire on a permanent basis.
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Shreeya Patel is recruiting an Associate Director of Regulatory Affairs and CMC to join a global pharmaceutical company based at their site in Hertfordshire on a permanent basis.
Click here to find out more
Please contact Shreeya for more details.
How to apply:
If you would like to apply or would like any information regarding these roles please contact Shreeya Patel on 01438 723 5670 or email spatel@ckclinical.co.uk
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Click here to search our current Pharmaceutical Regulatory Affairs roles online now.
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Tuesday, July 31st, 2012
Shreeya Patel at CK Regulatory is recruiting a Senior Regulatory Manager EU to join a global speciality pharmaceutical company in the South East on a permanent basis.
The job:
As the Senior Regulatory Manager EU you will be provided with an opportunity to gain experience across a range of submission types and strategies so this role would suit someone seeking to add to their current EU submission experience.
Responsibilities:
As Senior Regulatory Manager EU you will be responsible for the definition of regulatory strategy and subsequent implementation, in the EU and EEA regions. As Senior Regulatory Manager EU you will provide appropriate EU regulatory input to project teams to ensure planned drug development activities comply with EU guidelines and, in cases where they do not, you will provide a critical analysis of the risks and issues. As Senior Regulatory Manager EU you will define EU filing strategy (CP, MRP, DCP) identifying risks and issues. You will also ensure effective implementation of the filing plan, publishing and archiving of documents.
Qualifications:
As Senior Regulatory Manager EU you will be planning and implementing regulatory activities in support of lifecycle management. This role requires extensive experience in leading and running EU submissions in development, as well as scientific depth and the strong ability to influence. Someone who has recently held a position with autonomy would be preferable.
How to apply:
For further information about Senior Regulatory Manager EU role or to apply for the position please call Shreeya Patel on 01438 743 047 or email spatel@ckclinical.co.uk. Please quote reference CL24680 in all correspondence.
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Monday, July 30th, 2012
Shreeya Patel at CK Clinical is recruiting a Regulatory Manager, UK and Ireland to join a global pharmaceutical company based in the South East on a permanent basis.
Responsibilities:
The Regulatory Manager, UK and Ireland role supports the implementation of regulatory operational activities in the UK/Ireland and provides regulatory support for the registration and post-licensing of EU medicinal products in the UK/Ireland regions. The Regulatory Manager, UK and Ireland will also support the implementation of regulatory strategy in Europe and the EEA and will provide regulatory support for the registration and post-licensing activities of medicinal products.
Qualifications:
As Regulatory Manager, UK and Ireland you must have had direct UK and Ireland submissions experience in both renewals and variations. It is important that you have a pharmaceutical background with good direct interaction with UK and Ireland Health Authorities. Experience of artwork implementation is also essential.
Benefits:
This role provides great opportunities to gain experience and exposure to working within the EU lifecycle team as you will get the chance to work on EU projects. You will also be given the opportunity to interact with Global CMC and Global Labelling.
How to apply:
For more information about this Regulatory Manager, UK and Ireland position or to apply for this role please contact Shreeya Patel on 01438 743 047 or email spatel@ckclinical.co.uk
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Monday, February 20th, 2012
Cmed Clinical Services has appointed Geoff Fatzinger as Vice President of Global Medical and Regulatory Affairs, expected to bring his expertise from fifteen years as a regulatory professional, reports marketwatch.com.
Mr Fatzinger is expected to provide invaluable assistance in developing the new Medical and Regulatory Group established by Cmed, something he did successfully in his previous role at INC Research. Cmed CEO, David Connelly, believes Mr Fatzinger will be “a key building block in [Cmed’s] future business strategy.” He will be responsible for the company’s global Medical and Regulatory department.
Mr Fatzinger has a wealth of experience working with companies in Europe, Asia and North America and has spent his career in various areas around the world promoting and improving regulatory affairs, through his work and through lectures. He has said that “I am looking forward to the challenge, and making Cmed Clinical Services the industry’s first choice in quality partners for product development and product approvals.”
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Monday, January 23rd, 2012
Meera Pattni at CK Regulatory is currently recruiting for an Associate Director of Regulatory Affairs to join a hugely successful pharmaceutical company based in London.
Associate Director Regulatory Affairs Job Description
As Associate Director Regulatory Affairs you will responsible for the regulatory support of Oncology products by planning, managing and executing regulatory activities across the European territories for both investigational and marketed oncology products. You will also be involved in the development of innovative regulatory strategies for product development and approval of assigned oncology products.
Further responsibilities of this Associate Director Regulatory Affairs position include:
- Provide regional regulatory strategic guidance on assigned oncology development and marketed products.
- Plan, manage and execute regulatory activities in European territories as required on assigned oncology products.
- Serve as regional regulatory representative on relevant multi-functional team meetings.
- Advise functional areas regarding content requirements for regulatory submissions in the region and review documents for regulatory submission as required.
- Interface and work closely with EU counterparts to ensure clinical and commercial alignment to support regulatory activities on assigned projects.
- Manage and conduct meetings with regulatory authorities.
- Act as a point of contact for regulatory authorities for submissions on assigned projects.
- Evaluate new and revised regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.
- Undertake due diligence activities.
- Draft EU regulations/guidance and coordinate organisationa lreview of these/collate comments for feedback to industry
As Associate Director Regulatory Affairs you will have the following qualifications, skills and experience:
- Life sciences degree.
- Pharmaceutical/biological drug development experience.
- Proven European submissions capability, ideally in both pre-submission and post authorisation activities which must cover oncology experience.
- Experience in interactions with European Regulatory authorities in relation to all aspects of Regulatory activities.
- Detailed knowledge of EU regulations and guidelines on drug development and submissions.
- Knowledge of eCTD.
- Good negotiation and communication skills and the ability to work independently and function well in a team orientated environment.
How to apply:
Click here to apply now.
For more information, please contact Meera Pattni on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23541 in all correspondence.
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Thursday, December 8th, 2011
A global pharmaceutical company based in Buckinghamshire is looking for a Regulatory Affairs Director to join their team.
As Regulatory Affairs Director you will:
- Be a technical and regulatory specialist on NCE manufacturing and quality matters and to provide European regulatory and strategy on pharmaceutical development to regulatory colleagues and global project teams leading to successful registration of NCEs.
- Effectively liaise, negotiate and partner with European Regulatory Agencies.
- Liaise, negotiate and orchestrate meetings and teleconferences with National Regulatory Agencies and EMA; strategise and plan for Regulatory Agency meetings.
- Lead and manage the preparation of all quality related regulatory submissions (MAA, CTA, Amendments) for NCEs, including their line extensions and major variations during life cycle management to Agencies in accordance with European and National Directives.
- Assist in the preparation of regulatory strategy documents as requested.
- Participate in global project/product team meetings by applying regulatory expertise and knowledge of European requirements relating to manufacturing and quality.
- Liaise with functional groups within the Company related to assigned product/project areas to obtain/provide information/data for regulatory submissions.
- Mentor/instruct and provide guidance to internal and external parties including Consultants and CROs, as well as plan, assign and direct work.
- Review and interpret regulatory guidelines relating to NCE quality matters.
- Review RA and related documents for approval prior to submission.
As Regulatory Affairs Director you will have:
- Life sciences degree.
- Extensive experience within regulatory affairs.
- Specific experience in the development and registration of NCEs.
- Ability to manage and coordinate several projects simultaneously.
- Excellent interpersonal skills.
- Experience of managing CTAs and MAAs as well as associated documents including amendments and variation with regard to NCE quality.
- Recent experience of successful submissions/approval of a product in Europe.
How to apply:
For more information or to apply for this Regulatory Affairs Director position, please contact Meera Pattni at CK Regulatory on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23264 in all correspondence.
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Thursday, November 3rd, 2011
Meera Pattni at CK Regulatory is currently recruiting for a Regulatory Documentation Publisher to join a pharmaceutical company based in Basel.
The role:
As the Research Regulatory Documentation Publisher you will be required to support the submission process of scientific documents to the appropriate regulatory team. The publisher will be responsible for preparing scientific reports for regulatory submission use while supporting the department submission coordinator.
Responsibilities:
- Coordinating the different positions throughout the process of releasing internal scientific documents to Health Authority submissions requesting Clinical Trials.
- Formatting scientific reports in MS Word by applying corporate formatting standards.
- Ensuring timely input from authors & other positions and incorporating their input into appropriate documents.
- Managing quality control on selected reports at different stages of the process.
The ideal candidate:
Meera is looking for candidates with the following skills, experience and qualifications:
- Excellent communication skills in both written and oral English.
- Ability to manage multiple projects at once.
- Ability to work to deadlines.
- Proficiency in MS Word.
- Strong attention to detail.
- Willingness to think independently and take a flexible approach to documentation.
How to apply:
For more information or to apply for this Regulatory Documentation Publisher position, please contact Meera Pattni at CK Regulatory on 01438 743047 or email mpattni@ckregulatory.com. Please quote reference CL23069 in all correspondence.
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Monday, October 17th, 2011
Meera Pattni at CK Regulatory is recruiting for a Regulatory Affairs Engineer to be based in West Sussex.
The role:
As Regulatory Affairs Engineer, you will support the Quality and Regulatory Affairs Manager in achieving regulatory goals and objectives by proactively supporting the organisation in achieving the necessary regulatory submissions for the targeted markets. In addition, you will also be required to develop and maintain worldwide regulatory knowledge in the preparation of regulatory submissions and registrations.
Main responsibilities:
- Identify and provide advice and guidance on worldwide regulations throughout the organisation to ensure that up to date knowledge is maintained and implemented.
- Control the preparation and maintenance of submissions to regulatory authorities for all targeted markets.
- Collaborate with Compliance Engineers to provide Regulatory advice and guidance.
- Support Business Units and Distributors world wide during the tendering process byproviding supporting documentation and certification including Manufacturers Declarations.
- Provide regulatory determinations when required by CFR committees.
- Perform regulatory review on business documentation.
- Liaise with regulatory authorities.
- Advise on installation issues relating to new product development and the installed base.
The ideal candidate:
Meera is looking for candidates with the following skills and experience:
- Ability to interpret, adapt and provide guidance on product registration.
- Proven track record in regulatory affairs.
- Good communication skills.
- Previous experience within medical devices.
How to apply:
For more information or to apply for this Regulatory Affairs Engineer position, please contact Meera on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL22950 in all correspondence.
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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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