Regulatory Operations | CK Regulatory

Posts Tagged ‘regulatory operations’

Associate Director Job (Regulatory Operations) – Berkshire, UK

Friday, October 15th, 2010

Our client, a global pharma company, are currently looking for an Associate Director (Regulatory Operations) to join their team based in Berkshire, UK.

Reporting to the Executive Director of Regulatory Affairs, you will be responsible for the complete preparation and management of the publishing and submission of regulatory authorities in the EU. You will also organise and coordinate submissions in line with internal and external SOPs and provide advice and guidance to internal colleagues on submission issues. In addition, as part of your role as Associate Director, you will assist colleagues in the US with posting clinical trial information on the internet.

Main Responsibilities:

Preparation and management of the publishing, compilation and assembly of documents for various submissions.
Advise on submission strategy and take part in regular meetings.
Provide training to personnel and consultants on regulatory submission and review activities.
Assist in the writing of the SOPs.
Assist the US regulatory operations team as needed.
Keep up to date with European guidelines.
Communicate with outside consultants as required.
Take part in regulatory department meetings to transmit knowledge and discuss issues that need Reg Ops attention.

Person Specification:

To be considered for this Associate Director (Regulatory Operations) position, you must have the following qualifications and experience:

Hands on experience with publishing/submissions in the pharmaceutical industry.
Strong working knowledge of EU regulations.
Electronic publishing experience – CoreDossier, Documentum, etc.
Self sufficient.
Excellent leadership skills.
Good interpersonal skills.

Apply Now:

For more information, or to apply for this Associate Director (Regulatory Operations) role, please contact Meera Pattni on 01438 743 047 or email mpattni@ckregulatory.com.

Alternatively, click here to apply for this Associate Director position online now.

Not quite what you’re looking for? Click here to search our current Regulatory Affairs jobs online now.

Tags: associate director, Berkshire, Reg Affairs Jobs, Reg Affairs Recruitment, Regulatory Affairs Jobs, Regulatory Affairs recruitment, regulatory operations, uk
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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.

Senior Publisher based in Germany

Friday, March 26th, 2010

Our client specialises in scientific and industrial imaging for the life sciences sector. They are currently looking for a Senior Publisher to join their regulatory operations department. As Senior Publisher you will work closely alongside the Operations manager from the commencement of a client project through to the delivery of the finished product. You will be responsible for all of the processing and quality assurance activities of document management, PDF conversion and submission publishing. Up to 60% of travel is required for this role.

Further duties of this Senior Publisher role will include:

Paper preparation: performs reconciliation between the transmittal form and the received documents. Prepare and organise documents in accordance with company policies and FDA guidelines.
Scanning: must be familiar with the use of high speed scanners.
Indexing: performs indexing of pages to the project specific guidelines for indexing scheme.
Bookmarking: performs QA of bookmarks.
Hypertext linking: creates hyperlinks from Data Clarification Forms to assigned CRF pages.
Submission publishing: creates submissions in CTD, NeeS, and eCTD format.

The ideal candidate for this Senior Publisher job will have the following skills and competencies:

Highly IT literate with experience of Word, Powerpoint, and Excel.
Strong verbal and oral communication skills.
Ability to define and solve practical problems.
Ability to problem solve and multitask.

How to Apply

For more information, or to apply for this job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this Senior Publisher job now.

If this job is not exactly what you are looking for, you can search for other jobs in Regulatory Affairs here.

About CK Regulatory

CK Regulatory is a specialist Recruitment company offering job opportunities to Regulatory Affairs professionals seeking work in Pharma, Biotechnology, Medical Devices and Regulatory Consultancies. As part of CK Clinical we have an established and enviable track record of providing a high quality recruitment service to Pharmaceutical professionals.

In 2009, CK Regulatory work with many of the leading Pharmaceutical, Biotechnology and Medical Device companies offering more than just access to some of the best Regulatory jobs available but we also aim to make the job hunting and recruitment process as easy and enjoyable as possible.