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Associate Director Regulatory Affairs Job in London

Monday, January 23rd, 2012

Meera Pattni at CK Regulatory is currently recruiting for an Associate Director of Regulatory Affairs to join a hugely successful pharmaceutical company based in London.

 

Associate Director Regulatory Affairs Job Description

As Associate Director Regulatory Affairs you will responsible for the regulatory support of Oncology products by planning, managing and executing regulatory activities across the European territories for both investigational and marketed oncology products. You will also be involved in the development of innovative regulatory strategies for product development and approval of assigned oncology products.

Further responsibilities of this Associate Director Regulatory Affairs position include:

  • Provide regional regulatory strategic guidance on assigned oncology development and marketed products.
  • Plan, manage and execute regulatory activities in European territories as required on assigned oncology products.
  • Serve as regional regulatory representative on relevant multi-functional team meetings.
  • Advise functional areas regarding content requirements for regulatory submissions in the region and review documents for regulatory submission as required.
  • Interface and work closely with EU counterparts to ensure clinical and commercial alignment to support regulatory activities on assigned projects.
  • Manage and conduct meetings with regulatory authorities.
  • Act as a point of contact for regulatory authorities for submissions on assigned projects.
  • Evaluate new and revised regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.
  • Undertake due diligence activities.
  • Draft EU regulations/guidance and coordinate organisationa lreview of these/collate comments for feedback to industry

 

As Associate Director Regulatory Affairs you will have the following qualifications, skills and experience:

  • Life sciences degree.
  • Pharmaceutical/biological drug development experience.
  • Proven European submissions capability, ideally in both pre-submission and  post authorisation activities which must cover oncology experience.
  • Experience in interactions with European Regulatory authorities in relation to all aspects of Regulatory activities.
  • Detailed knowledge of EU regulations and guidelines on drug development and submissions.
  • Knowledge of eCTD.
  • Good negotiation and communication skills and the ability to work independently and function well in a team orientated environment.

 

How to apply:

Click here to apply now.

For more information, please contact Meera Pattni on 01438 870024 or email mpattni@ckregulatory.com.  Please quote reference CL23541 in all correspondence.

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Regulatory Affairs Associate Manager Jobs in Cambridge

Wednesday, January 18th, 2012

Meera Pattni is currently recruiting for two Regulatory Affairs Associate Managers to join a leading biopharmaceutical company based in Cambridge. To find out more, please watch her short video and read the job description below.

 

Regulatory Affairs Associate Manager Job Description:

As Regulatory Affairs Associate Manager, you will be working within the Emerging Markets team based in Cambridge. Your main responsibilities will include:

  • Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for commercial products for assigned territories in line with ICH requirements.
  • Responsible for submissions which may include safety reports, amendments, supplement and licence renewals and marketing authorisations.
  • Provide regulatory expertise to labelling changes and to submission teams in specified projects and topics.
  • Provide input to senior Regulatory Affairs professionals in the preparation of country specific labelling. Responsible for ensuring product packaging and associated information is updated and maintained in accordance with produce licences.
  • Participate in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to moderately complex programs/projects.
  • Responsible under guidance of immediate manager for own self development.

 

As Regulatory Affairs Associate Manager you will have the following skills, experience and qualifications:

  • A Life Sciences degree.
  • Relevant experience within regulatory affairs.
  • Experience within Emerging Markets essential.
  • Excellent organisational skills.
  • Flexibility with working hours
  • Excellent influencing skills

 

How to apply:

Click here to apply online now.

For more information about these Regulatory Affairs Associate Manager positions, please contact Meera Pattni on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23536 in all correspondence.

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Regulatory and Medical Affairs Officer Job in Watford

Tuesday, January 17th, 2012

Meera Pattni at CK Regulatory is currently recruiting for a Regulatory and Medical Affairs Officer to join a growing pharmaceutical company based in Watford, Hertfordshire.

 

Regulatory and Medical Affairs Officer Job Description

As Regulatory and Medical Affairs Officer, you will be responsible for maintaining marketing authorisations for both UK and Ireland to meet regulatory requirements. You will also provide a medical information service and monitoring/reporting of Pharmacovigilance cases to meet regulatory and legislative requirements.

Further responsibilities of this Regulatory and Medical Affairs Officer position include to:

  • Respond to medical and product enquiries received from healthcare professionals and members of the public.
  • Receive spontaneous reports of adverse events, follow up adverse events, communicate adverse events information to the central Pharmacovigilance department and report adverse event information to relevant regulatory authorities.
  • Receive, follow up, report and monitor customer complaints.
  • Review advertising and promotional material to ensure its compliance with relevant legislation and codes of practice.
  • Prepare and present Pharmacovigilance and ABPI training for both head office and field based staff.
  • Licence maintenance for existing marketing authorisations in the UK and Ireland.
  • Assist in compiling new MAA for UK and Ireland.
  • Coordinate artwork amendments and tracking of packaging modifications by liaising with appropriate personnel.
  • Prepare, submit and follow up applications for export certificates to the MHRA/IMB.
  • Compile, maintain and work to SOPs.

 

Qualifications, experience and skills required for this Regulatory and Medical Affairs position:

  • Previous experience within either medical or regulatory affairs is essential.
  • Knowledge of licence renewals beneficial.
  • Experience liaising with regulatory authorities required.
  • Life sciences degree essential.
  • Excellent interpersonal skills.
  • Ability to work independently.

 

How to apply:

Click here to apply online now.

For more information, please contact Meera Pattni at CK Regulatory on +44 (0) 1438 870024 or email mpattni@ckregulatory.com.  Please quote reference CL23491 in all correspondence.

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Regulatory Affairs Senior Associate Job in Buckinghamshire

Thursday, January 12th, 2012

Meera Pattni is currently recruiting for a Regulatory Affairs Senior Associate to join a successful Pharmaceutical company based in Buckinghamshire.

Regulatory Affairs Senior Associate Job Description

As Regulatory Affairs Senior Associate you will join the Development Group and will be working within the Neuroscience, Cardiovascular and Metabolism therapeutic areas. You will contribute to the development of new products or alternatively, you will support the maintenance of existing marketing authorisations and new registrations in emerging markets as part of the established markets group.

The main responsibilities of this Regulatory Affairs Senior Associate position will include:

  • Assisting in the preparation and submission of regulatory applications including MAAs in European and Emerging markets, variations and renewals.
  • Reviewing and commenting on regulatory documentation to ensure they are thorough and accurate.
  • Liaising with local affiliates, track regulatory approvals and respond to queries in a timely manner.
  • Ensuring clinical trial applications are complete and available according to agreed timelines.
  • Liaising and provide regulatory support to colleagues within EMEA regional and global R&D organisations.

To be considered for this Regulatory Affairs Senior Associate position you will have the following skills, experience and qualifications:

  • A Life Sciences degree.
  • Experience within European regulatory affairs.
  • Experience of MRP, DCP and CP preferable.
  • Excellent interpersonal skills.

How to apply:

To find out more and to apply for this Regulatory Affairs Senior Associate position, please contact Meera Pattni on 01438 870024 or email mpattni@ckregulatory.com.

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Regulatory Affairs Director Job in Buckinghamshire

Thursday, December 8th, 2011

A global pharmaceutical company based in Buckinghamshire is looking for a Regulatory Affairs Director to join their team.

As Regulatory Affairs Director you will:

  • Be a technical and regulatory specialist on NCE manufacturing and quality matters and to provide European regulatory and strategy on pharmaceutical development to regulatory colleagues and global project teams leading to successful registration of NCEs.
  • Effectively liaise, negotiate and partner with European Regulatory Agencies.
  • Liaise, negotiate and orchestrate meetings and teleconferences with National Regulatory Agencies and EMA; strategise and plan for Regulatory Agency meetings.
  • Lead and manage the preparation of all quality related regulatory submissions (MAA, CTA, Amendments) for NCEs, including their line extensions and major variations during life cycle management to Agencies in accordance with European and National Directives.
  • Assist in the preparation of regulatory strategy documents as requested.
  • Participate in global project/product team meetings by applying regulatory expertise and knowledge of European requirements relating to manufacturing and quality.
  • Liaise with functional groups within the Company related to assigned product/project areas to obtain/provide information/data for regulatory submissions.
  • Mentor/instruct and provide guidance to internal and external parties including Consultants and CROs, as well as plan, assign and direct work.
  • Review and interpret regulatory guidelines relating to NCE quality matters.
  • Review RA and related documents for approval prior to submission.

 

As Regulatory Affairs Director you will have:

  • Life sciences degree.
  • Extensive experience within regulatory affairs.
  • Specific experience in the development and registration of NCEs.
  • Ability to manage and coordinate several projects simultaneously.
  • Excellent interpersonal skills.
  • Experience of managing CTAs and MAAs as well as associated documents including amendments and variation with regard to NCE quality.
  • Recent experience of successful submissions/approval of a product in Europe.

 

How to apply:

For more information or to apply for this Regulatory Affairs Director position, please contact Meera Pattni at CK Regulatory on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23264 in all correspondence.

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Manager of EU Regulatory Affairs Job in Buckinghamshire

Wednesday, December 7th, 2011

Meera Pattni at CK Regulatory is currently recruiting for a Manager of EU Regulatory Affairs to be based in Buckinghamshire.

Job purpose:

As Manager of EU Regulatory Affairs you will provide European regulatory guidance and strategy to lead or support regulatory affairs projects and product maintenance in a manner that is scientifically sound, commercially viable and in accordance with regulatory standards.

Responsibilities:

  • Manage EU regulatory submissions to obtain timely approvals of Clinical Trial Applications and marketing authorisations for a project portfolio that spans from early phase through to marketed products.
  • Advise and inform on submission planning and ensure tracking of submissions.
  • Ensure QC checks of documents.
  • Proactively review, interpret and advise on regulatory guidelines and ensure high quality regulatory documents.
  • Lead and manage the preparation (content and format) of all assigned submission (CTAs, MAAs, variations, amendments, renewals to Agencies.
  • Manage and contribute to activities associated with registration and support of new and approved drug products.
  • Prepare gap analysis of clinical/technical documentation vs. regional and global requirements.
  • Assist in the development of strategies and advice in the development of pharmaceuticals and the maintenance of approvals.
  • Liaise, negotiate and communicate with functional groups within the Company.
  • Design, review and interpret regulatory guidelines and SOPs under the consideration of keeping current with European Regulatory guidelines and initiatives.

 

Ideal candidate:

To be considered for this Manager of EU Regulatory Affairs, you will have the following skills, experience and qualifications:

  • Life sciences degree.
  • Previous regulatory affairs experience essential.
  • Knowledge of drug development and marketing authorisations.
  • Experience managing CTA and MAA submissions.
  • Excellent interpersonal skills.

 

How to apply:

For more information or to apply for this Manager of EU Regulatory Affairs position, please contact Meera Pattni at CK Regulatory on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23263 in all correspondence.

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Head of R&D Regulatory Affairs Job in West Sussex

Wednesday, November 30th, 2011

Meera Pattni at CK Regulatory is currently recruiting for a Head of R&D Regulatory Affairs to join a successful pharmaceutical company based in West Sussex.

The role:

As Head of R&D Regulatory Affairs you will be responsible for ensuring  proper procedures and processes are in place to meet compliance needs. You will also ensure Pharmacovigilance activities are in line with SOPs.

Further responsibilities of this Regulatory Affairs position will include:

  • Develop UK Regulatory/Medical Affairs plans and take corrective actions when needed to ensur etimelines and objectives are achieved.
  • Develop/build on strong and sustainable relationships with Health Authorities to overcome barriers and expedite product registration processes.
  • Ensure customer excellence by delivering quality support for the Company’s project review boards and regional Innovation and BD&L process and collaborate to deliver planned sales aligned with annual business plans.
  • Monitor country government actions, legislation and OTC industrial organisation actions.
  • Ensure operational excellence through effective implementation of global regulatory information management and global labelling compliance initiative.
  • Ensure compliance review of the portfolio in collaboration with Region/Global QA.
  • Build drug regulatory affairs/medical affairs organisation in line with strategic plan.
  • Knowledge of global pharmacopeias, local and global regulations, compendiums, innovative new techniques.
  • MA submissions, approvals in line with Global / Region objectives.
  • RA Compliance review in line with annual plans.

The ideal candidate:

Meera is looking for candidates with the following qualifications, experience and skills:

  • Life sciences degree, educated to Masters level preferable.
  • Strong background in regulatory affairs.
  • Line management experience essential.
  • Pharmacist background preferable.
  • Understanding of local market business needs and environment.
  • Strong communication and negotiation skills.
  • Strong interpersonal skills.

How to apply:

For more information or to apply for this Head of R&D Regulatory Affairs position, please contact Meera Pattni at CK Regulatory on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23209 in all correspondence.

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Head of Regulatory Affairs Job in Wiltshire, UK

Tuesday, November 29th, 2011

Meera Pattni at CK Regulatory is currently recruiting for a Head of Regulatory Affairs to join a pharmaceutical company based in Wiltshire.

 

The role:

As Head of Regulatory Affairs, you will be responsible for the managerial leadership of the Regulatory Affairs and Pharmacovigilance departments to deliver the goals for the company projects and products. You will also provide leadership on development activities requiring Regulatory and Pharmacovigilance input in both US and EU.

Further responsibilities will include:

  • Provide leadership of the Regulatory and Pharmacovigilance activities to ensure the timely development of products.
  • Develop, gain approval for, and implement regulatory strategy for the company’s project and products and provide regulatory intelligence and advice throughout the company.
  • Recruit, train, develop and lead staff in order to maximise their contribution to the success of the company.
  • Propose and agree an annual budget for Regulatory Affairs Department, and manage the department within the budget.
  • Evaluate product development opportunities and support commercial discussions and negotiations.
  • Liaise with Regulatory Authorities and third parties as necessary.
  • Ensure compliance to internal and external procedures and guidelines to meet requirements of GCP.
  • Represent the Company in interactions with external organisations.

 

The ideal candidate:

To be considered for this Head of Regulatory Affairs you will have the following skills, experience and qualifications:

  • Life sciences degree.
  • Strategic management experience.
  • Experience of prioritising own and others workload.
  • Apply effective management skills to achieve results.
  • Ability to make decisions under pressure.
  • Ensure quality systems are implemented.

 

How to apply:

For more information or to apply for this Head of Regulatory Affairs position, please contact Meera Pattni on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23204 in all correspondence.

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Junior Medical Writer Job in Cambridge

Wednesday, November 23rd, 2011

A Junior Medical Writer is required to join a Regulatory Affairs Consultancy based in Cambridge. This is an excellent opportunity to work with a very busy and fast growing company with excellent prospects to progress. 

Key responsibilities:

  • Prepare tabulated summaries along with preparation of in-text tables or narratives for the Senior Medical Writers or Medical Writer.
  • Create of hyperlinks and bookmarks as required. 
  • Carry out numeric Quality Control of documents as required under the supervision of the Medical Writer. 
  • Plan schedule and track all assigned medical writing activities to ensure high quality, timely and accurate completion.
  • Provide regular status updates to the Medical Writer for all assigned medical writing activities.
  • Under supervision write low complexity CSR /NCSR. 
  • Compile current study reports within the EDMS environment
  • Requesting required documents from the client, or other departments as appropriate
  • Checking documents for compliance with EDMS requirements
  • Entering documents into the EDMS structure
  • Interact and effectively communicate with other groups in order to source clinical documents as required.
  • Assessing documents for completeness and quality
  • Produce documents using other software packages as required.
  • Perform any other activity as may reasonably be required from time to time. 
  • Complete all of the above activities within the framework and in compliance with ICH Guidelines, R&D SOPs and other documentation in force within the company

 

Location: Cambourne, Cambridge

Reference: MED_WR_02

Please reply with your CV and cover letter to jobs@elc-group.com

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Senior Regulatory Affairs Professional Job based in Cambridge, UK

Wednesday, November 23rd, 2011

An outstanding opportunity for a Senior Regulatory Affairs Professional to join a well established Regulatory Consultancy Company and play an instrumental role in the growth of the business.

Duties will include:

  • management of product licence registration and post registration activities with the appropriate regulatory authorities on a global basis
  • preparation of any regulatory dossiers and/or supporting documentation
  • supporting clients with the appropriate documentation to facilitate registration/maintenance of products
  • providing leadership and guidance to junior stuff and ensuring site activities comply with regulatory requirements.
  • reviewing and interpreting regulatory guidelines.
  • Providing in house training on regulatory topics as required
  • Supporting marketing and business development activities. This may include (but not be limited to):

-   advising on regulatory activities, timelines and costs for new business proposals as required

-   participating in new business meetings, kick off meetings and project meetings as required.

The candidate should be qualified in Life Sciences and have broad experience in pharma regulatory environments for US/EU markets. Sound knowledge of Global Regulatory Procedures, including marketing applications, negotiation and product licensing knowledge, proven success in agency influencing and negotiation are essential. Broad level of experience within the Pharmaceutical industry with knowledge of Regulatory Affairs and knowledge of product development is a must.

If you feel you have the relevant skills and experience for this role please send your application to jobs@elc-group.com. Please quote reference S_RAPM in all correspondence.

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