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Posts Tagged ‘ECTD’

Senior Regulatory Writer Job (Module 3) – Yorkshire, UK

Monday, September 20th, 2010

As Senior Regulatory Writer you will play a key role in this expanding team of Regulatory Authors based in Yorkshire, UK.

Our Client is a leading Healthcare and Pharmaceutical provider who consistently features in the top 100 places to work. You will coordinate the activities of the rest of the team of Module 3 authors as well as provide material yourself for Regulatory Excellence projects.

Key responsibilities of this Senior Regulatory Writer position will include:

Work collaboratively with other members of the Regulatory team and other personnel in R&D teams to provide documentation for existing products.
Take existing documentation and reformat, modifying as required, in the eCTD format.
Gather existing documentation from R&D teams
Identify gaps in documentation then obtain information/documents etc to plug the gaps.
Where license variations are submitted without a full Module 3 provide appropriate analytical & formulation documentation to support the variations.
Assist in the preparation of responses to questions arising from the submission of any documents prepared.

Apply Now

For more information, or to apply for this Senior Regulatory Writer position, please contact our regulatory recruitment team on 01438 743047 or email Jonathan (jhartsmith@ckregulatory.com) or Meera (mpattni@ckregulatory.com).

Alternatively, click here to apply for this Senior Regulatory Writer position online now.

Tags: ECTD, Reg Affairs Jobs, Reg Affairs Recruitment, Reg Affairs Yorkshire, Regulatory Affairs Jobs, Regulatory Affairs recruitment, Regulatory Affairs Yorkshire, regulatory writer, uk
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Regulatory Writer Job (Module 3) – Yorkshire, UK

Monday, September 20th, 2010

As a Regulatory Writer you will play an integral part of the Regulatory Affairs function in this expanding team of Regulatory Authors.

Our Client is a leading Healthcare and Pharmaceutical provider who consistently features in the top 100 places to work. You will join an expanding team of Module 3 authors to write and produce material for submission as part of Regulatory Excellence projects.

Other responsibilities of this Regulatory Writer position will include:

Work collaboratively with other members of the Regulatory team and other personnel in R&D teams to provide documentation for existing products.
Take existing documentation and reformat, modifying as required, in the eCTD format.
Gather existing documentation from R&D teams
Identify gaps in documentation then obtain information/documents etc to plug the gaps.
Where licence variations are submitted without a full Module 3 provide appropriate analytical & formulation documentation to support the variations.
Assist in the preparation of responses to questions arising from the submission of any documents prepared.

Apply Now

For more information about this Regulatory Writer role or others we are handling please contact our regulatory recruitment team on 01438 743047 or email Jonathan (jhartsmith@ckregulatory.com or Meera (mpattni@ckregulatory.com).

Alternatively, click here to apply for this Regulatory Writer role online now.

Not quite what you’re looking for? Click here to search our current regulatory affairs positions online now.

Tags: ECTD, module 3, Reg Affairs Jobs, Reg Affairs Recruitment, Reg Affairs Yorkshire, Regulatory Affairs Jobs, Regulatory Affairs recruitment, Regulatory Affairs Yorkshire, regulatory writer, uk
Posted in Featured Job, News | No Comments »

Head of Regulatory Operations – Essex, UK

Thursday, July 15th, 2010

As Head of Regulatory Operations, you will be responsible for all communication to the regulatory authorities including regulatory submissions. You will be responsible for ensuring that the regulatory submissions are compliant with current guidelines.

The main responsibilities of this Head of Regulatory Operations role will include:

Managing all communications with Regulatory Authorities.
Ensuring an appropriate tracking system is in place and maintained.
Creating and managing the submission of regulatory dossier across different regions and ensuring compliance with the appropriate authorities.
Ensuring the format of the dossiers are compliant with internal and external guidelines.
Keeping up to date with changes in guidelines and legislations and communicating these throughout the department.
Providing advice and guidance to cross functional teams on the structure of regional dossiers.
Helping develop the operations department and providing advice on process improvements.

The ideal candidate for this Head of Regulatory Operations role will have the following experience and attributes:

Must have previous regulatory operations experience.
Line management experience.
Strong knowledge and understanding of EU regulatory authorities.
Process and detail driven.
Experience with CTD highly beneficial.

Apply now

For more information, or to apply for this Head of Regulatory Operations role, please contact Jonathan Hart-Smith on 01438 743 047 or email jhartsmith@ckclinical.co.uk.

Tags: : Head of Regulatory Operations, ECTD, Essex, Regulatory Affairs Jobs, Regulatory Affairs recruitment, regulatory operations, regulatory publishing, Regulatory Submissions, uk
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Head of Regulatory Operations – Essex

Wednesday, July 14th, 2010

The main responsibilities of this Head of Regulatory Operations role will include:

Managing all communications with Regulatory Authorities.
Ensuring an appropriate tracking system is in place and maintained.
Creating and managing the submission of regulatory dossier across different regions and ensuring compliance with the appropriate authorities.
Ensuring the format of the dossiers are compliant with internal and external guidelines.
Keeping up to date with changes in guidelines and legislations and communicating these throughout the department.
Providing advice and guidance to cross functional teams on the structure of regional dossiers.
Helping develop the operations department and providing advice on process improvements.

The ideal candidate for this Head of Regulatory Operations role will have the following experience and attributes:

Must have previous regulatory operations experience.
Line management experience.
Strong knowledge and understanding of EU regulatory authorities.
Process and detail driven.
Experience with CTD highly beneficial.

Apply now

For more information, or to apply for this Head of Regulatory Operations role, please contact Jonathan Hart-Smith on 01438 743 047 or email jhartsmith@ckclinical.co.uk.

Head of Regulatory Operations – Essex, UK

Wednesday, June 30th, 2010

An emerging global pharmaceutical enterprise is looking for a Head of Regulatory Operations to join their team based in Essex, UK.

As Head of Regulatory Operations, you will mainly be responsible for all communication to the regulatory authorities including regulatory submissions. You will also be responsible for ensuring that the regulatory submissions are compliant with current guidelines.

Further key responsibilities of this Head of Regulatory Operations role will include:

To manage all communications with Regulatory Authorities.
To ensure an appropriate tracking system is in place and maintained.
To create and manage the submission of regulatory dossier across different regions and ensure compliance with the appropriate authorities.
To ensure the format of the dossiers are compliant with internal and external guidelines.
To keep up to date with changes in guidelines and legislations and communicate these throughout the department.
To provide advice and guidance to cross functional teams on the structure of regional dossiers.
To help develop the operations department and provide advice on process improvements.

To be considered for this Head of Regulatory Operations job you will be process and detail driven and will have demonstrable experience in the following:

Regulatory operations
Line management experience.
Strong knowledge and understanding of EU regulatory authorities.
Experience with CTD

Apply now

For more information, or to apply for this Head of Regulatory Operations job, please contact Meera Pattni on +44 (0)1438 743047 or email: mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this Head of Regulatory Operations job online now.

Not quite what you’re looking for? Click here to search our current regulatory affairs jobs now.

Regulatory Affairs Associate Director

Thursday, October 8th, 2009

Regulatory Affairs Associate Director

Leading a team of highly experience Regulatory Affairs Executives and directly supporting the Global Director of Regulatory Affairs, this role presents an interesting and exciting challenge to an experience Regulatory Manager.

Our client, a European pharmaceutical group with a total worldwide staff of over 4,000 and currently marketing more than 20 products, requires an Regulatory Affairs Associate Director, for the Global Regulatory Operations team.

Main purpose of the role:

· To manage all internal and external resources required to ensure quality regulatory publishing and submissions worldwide.

· To design and ensure implementation of a strategy for Global dossier management, including development of eCTD facilities, in order to ensure state of the art regulatory submissions and adaptation to evolution of regulatory agencies requirement.

· To manage a Global team in charge of Dossier Management and provide adequate support to internal departments.

The position is hosted in Global Regulatory Affairs and reports to the Director, Global Regulatory Affairs Operations

A full and detailed job description available upon request.

Application details

For further details, please contact Samantha or Jonathan on 01438 743047.

If this vacancy is not exactly what you are looking for why not give us a call, we may be dealing with a vacancy better suited to your needs.

Tags: ECTD, EDMS, electronic submissions, MAA’s, Publishing, Regulatory Affairs, Regulatory Affairs Associate Director, Regulatory Affairs Manager, Submissions
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Posts Tagged ‘ECTD’

Senior Regulatory Writer Job (Module 3) – Yorkshire, UK

Regulatory Writer Job (Module 3) – Yorkshire, UK

Head of Regulatory Operations – Essex, UK

Head of Regulatory Operations – Essex

Head of Regulatory Operations – Essex, UK

Regulatory Affairs Associate Director

Regulatory Affairs Associate Director

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