Posts Tagged ‘Pharmaceutical regulatory affairs jobs’
Tuesday, July 24th, 2012
Shreeya Patel at CK Regulatory is recruiting for a Global Regulatory Lead to join a leading healthcare company based in Surrey on a permanent basis.
Global Regulatory Lead Job Description
As Global Regulatory Lead you will be responsible for:
- Providing regulatory input into key projects and managing all regulatory activities related to that project.
- Working on projects where their particular expertise or experience can bring an additional benefit.
- Leading a team within Regulatory Affairs responsible for the registration of new products.
- Directing activities and managing the resources required to provide regulatory input into assigned projects and to develop effective regulatory strategies for assigned projects which meet business goals.
- Contributing specific expertise to Regulatory Authorities in a defined area and advise other members of the department/company as appropriate.
- Providing extensive knowledge of assigned products, including understanding of competitors and any additional area of regulatory expertise that is important for the business (eg. devices, biotech).
As Global Regulatory Lead your role will be fairly autonomous and decision making responsibilities will be defined by the tasks at hand limited to the maintenance and tactical level business implementations.
How to Apply:
Click here to apply online now >
For more information regarding this Global Regulatory Lead position, please contact Shreeya Patel on +44 (0)1438 743 047 or email spatel@ckclinical.co.uk. Please quote reference CL24823 in all correspondence.
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Tuesday, July 17th, 2012
Shreeya Patel is recruiting for a Hub Labelling Manager to join a pharmaceutical company at their Surrey site on 12 month contract.
Hub Labelling Manager Job Description
The Hub Labelling Manager is responsible for executing the content management of local product documents regardless of registration procedure. As Hub Labelling Manager you will keep up to date with regional labelling regulations. The role will also oversee content across all labels for their assigned products in their assigned regions and be consistent wherever possible.
As Hub Labelling Manager you will be reporting into the locally based Regional Labelling Team Leader. The Hub Labelling Manager will be expected to utilize regulatory expertise to review, develop and deliver core labelling documents such as the LPD and Patient Leaflet to support submissions to the Regulatory Authorities across regions, requesting medical advice from others when appropriate.
Qualifications, Skills and Experience:
As Hub Labelling Manager you must be able to demonstrate the ability to interpret and apply regional/local regulatory guidance around labelling and associated supportive documentation, both pre and post approval. You must also have a proven strength in logical, analytical and writing ability with complete fluency in the English language.
How to Apply:
Click here to apply online now.
For more information or to apply for the Hub Labelling Manager position please contact Shreeya Patel on 01438 743 047 or email spatel@ckclinical.co.uk.
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Wednesday, July 4th, 2012
Shreeya Patel is recruiting a Senior Regulatory Manager EU to join a global speciality pharmaceutical company in the South East on a permanent basis.
Senior Regulatory Manager Job Description:
As 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.
- Providing 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
- Defining EU filing strategy (CP, MRP, DCP) identifying risks and issues
- Ensuring effective implementation of the filing plan, publishing and archiving of documents.
- Planning and implementing regulatory activities in support of lifecycle management
This Senior Regulatory Manager 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 or to apply for this 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.
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Friday, June 29th, 2012
Shreeya Patel at CK Regulatory is currently recruiting for a Regulatory Associate Medical Devices to join a global clinical research organisation at their side based in Hertfordshire on a contract basis.
As Regulatory Affairs Associate your main purpose will be to:
- Provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures.
- Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects
- Acquire pertinent regulatory information from agencies and organizations
- Support regulatory agency interactions, communications, and submissions
- Review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.
- Coordinate and communicate with local CRAs to obtain relevant information
How to apply:
Click here to apply online now.
For more information regarding this Regulatory Associate Medical Devices, please contact Shreeya Patel on +44 (0)1438 870 024 or email spatel@ckclinical.co.uk. Please quote reference CL24467 in all correspondence.
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Tuesday, November 8th, 2011
Meera Pattni at CK Regulatory is currently recruiting for a Senior ePublisher to join a highly successful Pharmaceutical company based in Hertfordshire, UK.
The role:
As Senior ePublisher, you will be responsible for supporting the maintenance of eCTD Lifecycles. You will be involved in formatting of word documents, pre and post publishing activities, along with QC as necessary.
Main responsibilities:
- Responsible for supporting lifecycle publishing projects for MAAs including NT/DCP/CP and MRP submissions.
- Responsible for supporting NeeS and paper submissions as required.
- Liaising with Senior Global Operations management and RA staff as required.
- Assisting with formatting of word documents, post publishing and QC when necessary.
- Support internal process development.
- Ensuring all quality standards are upheld PQC.
- Supporting internal DMS management and workflows.
- Strategising activities in support of management projects.
- Maintenance of all internal archiving procedures.
- Supporting presentations when necessary within group and submission project team meetings.
- Interaction with EU affiliates as required.
The ideal candidate:
Meera is looking for candidates with the following skills, experience and qualifications:
- Regulatory operations experience is essential.
- Hands on experience with electronic publishing (NeeS/eCTD).
- Experience of following systems and programs eDMS/Adobe Acrobat Professional.
- Preferably a life sciences degree.
- Excellent Adobe Acrobat skills.
How to apply:
For more information or to apply for this Senior ePublisher role, please contact Meera Pattni at CK Regulatory on +44(0)1438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23087 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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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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