A Senior Regulatory Director is required to join a global pharmaceutical company based in Hertfordshire, UK.
As Senior Regulatory Director, the main purpose of your role will include:
To effectively manage, train and develop direct reports and others involved in the emerging markets team.
To ensure regulatory strategies and contributions to all projects are delivered in a timely manner to agreed costs.
Ensure regulatory compliance strategies are adhered to.
The main responsibilities of this Senior Regulatory Director job will include:
Provide oversight of all in country registrations and maintenance activities for the emerging markets territories.
Take responsibility for all regulatory planning and strategic activities for the target countries.
Oversee all teams and personnel responsible for China, Canada, Europe and Eastern Asia.
Directing pricing strategies, and market penetration practices.
Strategically supporting commercial products from a marketing stand point.
Take part in external initiatives to influence the development of regulatory environments.
Developing and guiding the global regulatory strategy.
The ideal candidate for this Senior Regulatory Director job will have experience both within the emerging markets division and also of submissions in Canada, China, UK and Asian markets.
Apply Now
For more information, or to apply for this Senior Regulatory Director role, please contact Meera Pattni on Tel: +44 (0)1438 743047 or email mpattni@ckclinical.co.uk.
Our client, a global pharmaceutical company based in Berkshire, is currently looking for a Director of Regulatory Affairs to join their team.
As the Director of Regulatory Affairs you will provide European regulatory guidance and strategy to your regulatory colleagues and global project teams leading to sound scientific development programs and successful registration for new biological compounds and new indications.
This Director of Regulatory Affairs role will also include the following key responsibilities:
You will liaise, negotiate and partner with European Regulatory Agencies. Represent the company during Agency (National/EMA) interactions
Schedule and lead meetings with Agencies and prepare company personnel for Agency interactions.
Determine the content for the Quality related section of regulatory submissions as well as evaluate submissions for accuracy.
You will also prepare regulatory responses to requests from health authorities and meet aggressive deadlines to ensure that regulatory Agencies receive timely and scientifically robust submissions, shortening the review process and leading to successful approval of biological products for the company’s growth thereby accomplishing corporate goals.
What makes this Director of Regulatory Affairs role different?
Our Client is truly a leader in its field. You can expect a smaller company feel providing you with room to grow and influence others but with the financial backing and security of an established corporate organisation. If you want to not only make a difference to the end users and patients but also help shape the way that the European Regulatory department function then this is an ideal opportunity. It will give you strategic and operational input and responsibilities.
Apply now
For more information, or to apply for this Director of Regulatory Affairs position, please contact Jonathan Hart-Smith on 01438 743047 or email: jhartsmith@ckclinical.co.uk.
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.
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.
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.
A number of Regulatory Consultants are required to join a Regulatory Affairs Consultancy to work at their sites based in Belgium, the Netherlands, Germany, Spain and Greece.
The main focus of these Regulatory Consultants jobs will include:
Dealing with translation houses (may be required to do translations yourselves)
Dealing with submissions for Generic products.
Filing DCPs, MRPs, Nationals and Duplicates on behalf of the organisation.
Liaising with CMS and RMS
Working on National phase of MRP and DCP, you will be required to work closely with the local agency.
Products include solid doses, some liquids and some steriles.
The ideal candidates for these Regulatory Consultants roles will have previous generics experience and will be fluent in both the local language and in English.
These Regulatory Consultant jobs are 12 month contract jobs and you will be required to start ASAP at a rate of €60 per hour.
Apply Now
For more information, or to apply for these Regulatory Consultant jobs, please contact Meera Pattni on 01438 743 047 or email mpattni@ckclinical.co.uk.
A Regulatory Affairs Associate is required to join a health and personal care company based inYorkshire, UK.
As Regulatory Affairs Associate you will join a global regulatory affairs team which are responsible for handling regulatory affairs submissions to competent authorities around the world.
The main responsibilities of this Regulatory Affairs Associate role will include:
To develop and implement regulatory strategy for the assigned product Category.
To achieve marketing authorisations for products in key global markets.
To be the central point for submissions in key global markets.
To lead projects to gain authorisations in key global markets.
Keep on top of the ever changing Legislative environment and ensure that all relevant parties are kept up to date with the changing legislative scene.
Assist in the preparation of documentation in a way that regulatory authorities are likely to accept and deal with constant changes which require regulatory action.
Meeting business / project deadlines in a busy environment.
Building relationships with regulatory personnel around the World.
Able to respond to last minute requests.
To be able to manage expectations and suggest workable alternatives.
The main USP’s of this Regulatory Affairs Associate role are as follows:
The company you will be joining will empower you with as much responsibility as you need in order to develop your skills and expertise.
You will be developed in a fast track environment.
If you have some experience of regulatory affairs but have some areas that require further training you will receive this.
It is a fast paced place to work ensuring that there is never a dull moment.
Aligned to a Brand team you will have lots of responsibility and ownership for your product / therapy area from a regulatory perspective.
The ideal candidate for this Regulatory Affairs Associate job will have previous experience of working within R&D in the pharmaceutical industry as well as practical experience of working within Regulatory affairs ideally as part of the submissions team.
Apply Now
For more information, or to apply for this Regulatory Affairs Associate job, please contact Jonathan Hart-Smith on 01438 743 047 or email jhartsmith@ckclinical.co.uk.
A Regulatory Affairs Manager is required to join one of the largest pharmaceutical companies in the world at their site based in Hertfordshire, UK.
Reporting to the Head of Regulatory Affairs, the main roles and responsibilities of this Regulatory Affairs Manager job will include:
Maintenance of national product MAAs for the company.
Work with global colleagues to ensure maintenance of globally supported products.
Work closely with the Quality and Manufacturing team about regulatory issues affecting maintenance of licences and new product registration.
Work closely with the R&D team to ensure new products are developed in a timely fashion in accordance with regulatory guidelines.
Advice and support other departments on regulatory issues.
Review promotional material for compliance with regulatory guidelines.
The ideal candidate for this Regulatory Affairs Manager job will be educated to degree level or preferably PhD level in veterinary medicine or sciences. This Regulatory Affairs Manager job also demands a candidate with three years of Regulatory Affairs experience, ideally with a background in biological veterinary medicinal products.
Apply Now
For more information, or to apply for this Regulatory Affairs Manager job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.
Regulatory Publisher based in Hatfield, Hertfordshire, UK.
As Regulatory Publisher you will primarily be responsible for publishing eCTD sequences for centralised, MRP, DCP submissions. Reporting to the Senior Manager of Global Regulatory Operations, you will be expected to self manage each project by working closely with regulatory, clinical and CMC leads wherever necessary. Working as Regulatory Publisher you will also be expected to support major submissions publishing project by assisting in formatting of word documents, bookmarking, hyperlinking and QC when necessary.
Key responsibilities of this Regulatory Publisher role will include:
Publish eCTD sequences for centralised, MRP and DCP submissions.
Updates and issues communicated during management meetings.
Support Major Submissions Publishing projects.
The successful candidate for this Regulatory Publisher job will have previous experience of publishing eCTD sequences. In addition, the following skills and competencies are also essential for this Regulatory Publisher role:
Excellent verbal and written communication skills.
Ability to gather necessary information when required for assigned eCTD life cycle projects.
Ensure lifecycle and publishing projects are processed in accordance with agency guidelines and SOPs.
Understanding of lifecycle management.
Ability to present information in a clear and concise manner.
Knowledge of ICH regulations and guidelines.
How to Apply for this Regulatory Publisher Job:
For more information, or to apply for this Regulatory Publisher job, please contact Meera Pattni on +44 (0)1438 743047 or email mpattni@ckclinical.co.uk/
