Senior Regulatory Consultant

• Location: Hertfordshire and will consider up to a 60 minute commute each way.
• Reference:  101689

-          Over 20 years experience in regulatory affairs.

-          Hands on experience with many documents including MAAs and CTAs.

-          Experienced at developing regulatory strategy.

-          Strong working knowledge of EU regulatory affairs.

-          Available immediately and looking for around £70p/h.

Regulatory Submissions Specialist

• Location: Berkshire, M4 corridor
• Reference: 84558

-          Experience using multiple publishing tools including Documentum and eCTD Xpress.

-          Hands on experience of compiling, reviewing and publishing regulatory submissions to EU authorities.

-          Excellent attention to detail and organisation skills.

-          Currently on a 4 week notice period.

Regulatory Associate

• Location: Harrow and will consider up to a 60 minute commute each way
• Reference: 103286

-          Strong post marketing experience including initiation, review and approval of artwork.

-          MHRA portal administrator, this includes making and tracking submissions.

-          Currently assists colleagues with EU submissions/filings including variations, MAAs, CTAs and PIPs.

-          Liaises closely with colleagues in other departments to ensure regulatory compliance.

-          Currently on a 4 week notice period and looking for a Senior Associate level role.

The additional usage will be in order to put active immunisation in place against pneumonia for children from six weeks to five years old. GSK has submitted the application to the EMA as a variant to the marketing authorisation already in place.

Synfolrix is currently approved across the EU and in 90 other countries as an immunisation against invasive diseases and other illnesses caused by the same bacterium which can cause pneumonia in children under five. Over two thirds of these countries have already approved Synflorix for use against pneumonia.

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Medical Writer / Regulatory Doc Scientist – Hertfordshire  

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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Associate Director, Reg Affairs, CMC

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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Senior Associate – Hertfordshire

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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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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Responsibilities:

As Product Surveillance Project Associate your role will be to manage, analyse and create reports in response to requests for information. You will also identify and manage process improvement projects in response to audit findings, system analysis, internal requests and personal experiences from you and the team.

Qualifications:

As Product Surveillance Project Associate you must have worked with Medical Devices, either in a QA role, regulatory role or even from a complaints team within medical devices.

How to apply:

Apply now:

For more information or to apply for this Product Surveillance Project Associate role, please contact Shreeya Patel on 01438 743 047 or email spatel@ckclinical.co.uk.  Please quote reference CL24955 in all correspondence.

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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 and skills:

As Regulatory Manager, UK and Ireland you must have had direct UK and Ireland submissions experience in both renewals and variations. The Regulatory Manager, UK and Ireland would also have a pharmaceutical background with good direct interaction with UK and Ireland Health Authorities. Experience of artwork implementation is also essential for the Regulatory Manager, UK and Ireland position.

Opportunities:

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. The Regulatory Manager, UK and Ireland 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. Please quote reference CL24685 in all correspondence.

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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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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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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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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.

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.

Not quite what you’re looking for?

Click here to search our current Pharmaceutical Regulatory Affairs roles online now.