Posts Tagged ‘uk’

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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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.

Regulatory Affairs Professional Job based in Cambridge, UK

Wednesday, November 23rd, 2011

An outstanding opportunity for a Regulatory Affairs professional to join a well established Regulatory Consultancy Company and play an instrumental role in the growth of the business. You will be responsible for identifying and developing new business to ensure the regulatory sales targets are met or exceeded.

The person

Suitable candidates will have a background in sales / marketing of a scientific consultancy service. You will have sound knowledge of Global Regulatory Procedures, including marketing applications, negotiation and product licensing knowledge, proven success in agency influencing and negotiation. Broad level of experience within the Pharmaceutical industry with knowledge of Regulatory Affairs and knowledge of product development is a must.

You must have excellent communication skills, be a good listener, be commercially minded and able to develop complex and diverse proposals / solutions for clients’ requirements.

You will have the ability to network with colleagues and co-workers appropriately and to manage the communication to and collaboration of decision-making members of each project team. 

Typical activities may include:

  • Providing regulatory strategy and technical consultancy for the Regulatory Affairs Business Development Team and Project Management Team as well as regulatory consultancy and strategic advice to the clients;
  • Reviewing and providing technical advice to prepare regulatory submissions;
  • Contributing to development and implementation of global and regional regulatory functions;
  • To assist in business development in securing new business and making presentations to clients;
  • Maintaining and developing relationships with existing customers via meetings, telephone calls and emails;
  • Visiting potential customers to prospect for new business;
  • Acting as a contact between a company and its existing and potential markets;
  • Negotiating the terms of an agreement and closing sales;
  • Gathering market and customer information;
  • Representing the organization at trade exhibitions, events and demonstrations;
  • Negotiating variations in price, delivery and specifications with managers
  • Advising on forthcoming product developments and discussing special promotions;
  • Liaising with Project Managers to check on the progress of existing orders;
  • Recording sales and order information and sending copies to the sales manager;
  • Reviewing own sales performance, aiming to meet or exceed targets;
  • Gaining a clear understanding of customers’ businesses and requirements.    

Offer:

• Competitive basic salary
• Attractive commissions package with no caps
• Bonuses 

 

How to apply:

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

Location: Cambourne, Cambridge

Ref: RABD_1

Regulatory Affairs Officer Job in West Yorkshire, UK

Tuesday, November 1st, 2011

Meera Pattni at CK Regulatory is currently recruiting for a Regulatory Affairs Officer to join a pharmaceutical company which specialises in the development and marketing of oral liquid medicines.

The role:

As Regulatory Affairs Officer you will help to collate documents in preparation for variations and Marketing Authorisation Applications.

Main responsibilities:  

  • Advise departments of regulatory information regarding approved shelf life, suppliers etc.
  • Help collate documents for Marketing Authorisation Applications.
  • Prepare type I and II variations.
  • Apply for Export Certificates including legislation and notarisation as necessary.
  • Regulatory administrative tasks.
  • Initiation of packaging around the internalsystem and initial checks.

 

The ideal candidate:

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

  • Life sciences degree.
  • Previous experience within regulatory affairs highly desirable.
  • Ability to work to deadlines.
  • Good written language skills.
  • Ability to solve problems.

 

How to apply:

For more information or to appy for this Regulatory Affairs Officer position, please contact Meera Pattni on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23048 in all correspondence.

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Associate Director of Regulatory Affairs Job in North West, UK

Tuesday, October 11th, 2011

Meera Pattni at CK Regulatory is currently recruiting for an Associate Director of Regulatory Affairs to be based in the North West of England.

Responsibilities:

  • Direct and prepare regulatory submissions as required for global approvals for IVDs, including preparation of reports and interaction with regulatory officials.
  • Review product labelling and promotional literature for regulatory compliance.
  • Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with global regulatory agencies.
  • Liaise with regulatory agencies for enquiries and issues.
  • Review R&D protocols and technical reports and other company documents for use in regulatory submissions and in response to questions from regulatory authorities.
  • Oversee and direct the preparation of regulatory documentation for country specific registrations.
  • Develop regulatory SOPs relevant for registration of IVD products or other regulatory aspects.

 

Person specification:

  • Extensive experience in the medical device industry, preferably with IVD experience and extensive regulatory affairs experience.
  • Experience in the preparation and submission of 510K, PMAs, IND, CE Design Dossiers, CE Technical Files.
  • Possess a working knowledge of MDD and IVDD, applicable ISO standards.
  • Ability to work as part of a team.
  • Excellent influencing and negotiating skills.
  • Excellent verbal and written communication skills.

 

How to apply:

For more information or to apply for this Associate Director of Regulatory Affairs position, please contact Meera on 01438 870024 or email a copy of your CV to mpattni@ckregulatory.com. Please quote reference CL22924 in all correspondence.

Global Regulatory Affairs CMC Associate Job in Yorkshire, UK

Monday, October 3rd, 2011

Meera Pattni at CK Clinical is recruiting for a Global Regulatory Affairs CMC Associate to join a successful and innovative pharmaceutical company at their site in Yorkshire, UK.

 

The job:

As Global Regulatory Affairs CMC Associate, you will be required to assist the new product development and existing product development projects within the scope of the global regulatory CMC team. You will also assist and support regulatory CMC strategy and deliver submissions.

Responsibilities:

  • Deliver global regulatory affairs CMC project activities by effective coordinator, strategy and implementation.
  • Prepare and deliver regulatory submissions including CTAs, MAAs, INDs and variations/renewals in line with defined CMC plans.
  • Work collaboratively with appropriate company personnel and contractors to coordinate the regulatory work stream elements for CMC activities.
  • Liaise with regulatory authorities as required.
  • Maintain documented regulatory project plans in line with best practice recommendations.
  • Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the CMC team.

 

The ideal candidate:

Meera is looking for candidates will the following skills:

  • Excellent communication skills.
  • Highly organised.
  • Ability to handle multiple projects at once.
  • Results orientated.
  • Strong negotiating and interpersonal skills.
  • Openness to change.

 

How to apply:

For more information or to apply, please contact Meera on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL22877 in all correspondence.

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EC Approve Roche’s Tarceva

Friday, September 2nd, 2011

Pharmaceutical-business-review.com has reported that French pharmaceutical company Roche has received approval from the European Commission (EC) for lung cancer drug Tarceva.

The drug can now be used as a treatment on it’s own to treat patients with locally advanced or metastatic lung cancer. Prior studies have shown that Tarceva nearly doubles the amount of time patients survive without their cancer progressing when compared to chemotherapy.

Hal Barron, Roche’s head of Global Product Development and chief medical officer believes the European approval to be good news for those with genetically distinct forms of the cancer because they can receive a greater benefit when the medicine is used as an initial treatment.

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GSK Parkinsons Trials Post Positive Results

Tuesday, August 16th, 2011

Pharmaceutical giant GlaxoSmithKline’s new Parkinson’s drug has been seen to help patients retain their motor skills following the medication wearing off, reports inpharm.com.

In a phase III trial, the drug significantly increased patients’ time without needing to use the drugs whilst their motor skills did not decline any further. The drug decreased patients off time, where they suffer from Parkinson’s symptoms, by 33.5% from the standard baseline. This represents over two hours more time that patients report that they are symptom free following taking their medication.

Impax Pharmaceuticals, who developed the drug with GSK, said they are “excited to report these positive results.” Under the agreement between the companies, Impax holds the rights to the drug in the US and Taiwan, with GSK holding the rights in every other market. GSK plans to apply for marketing rights in the EU early in 2012.

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Regulatory Affairs Therapy Area Head Job – Berkshire, UK

Monday, August 8th, 2011

Meera Pattni at CK Regulatory is looking for a Regulatory Affairs Therapy Area Head to join a large Pharmaceutical company based in Berkshire.

The role:

As Regulatory Affairs Therapy Area Head, you will work within Immunology, Virology, Neonataology and Oncology. CNS/Pain groups. Your main responsibilities will include:

  • You will be responsible for setting and implementing regulatory strategy for the assigned therapeutic area.
  • Represent Regulatory Affairs on Brand Teams.
  • Lead and support regulatory personnel in the affiliate groups, through ongoing communication and development, as well as training and mentoring of local Regulatory Leaders.

 

The ideal candidate:

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

  • Previous experience in a Senior level regulatory position within the pharmaceutical industry.
  • Excellent understanding of the regulatory requirements for the Western Europe and Central/Eastern Europe and Russia regions.
  • Existing network of regulatory authority contacts in the relevant markets.
  • Excellent communication skills, knowledge of a second language would be an advantage.
  • Previous experience developing regulatory strategy required.

 

How to apply:

For more information or to apply for this Regulatory Affairs Therapy Head, please contact Meera Pattni on 01438 743 047 or email mpattni@ckregulatory.com.

Pharma Giant Pushes Epilepsy Drug as Treatment

Thursday, July 28th, 2011

Pharmaceutical giant Eisai has been granted an extended European licence for the drug Zonegran, reports Pharmaceutical Business Review.

Zonegran, an antiepileptic drug, has been accepted as an adjunctive therapy for epilepsy treatment and Eisai are applying to have the drug used as a stand alone therapy for epilepsy patients with partial seizures.

The application for a mono-therapy was given following a blind, random trial comparing Zonegran to another treatment and involved nearly 600 newly diagnosed patients. The trial showed that those who used Zonegran as a mono-therapy tolerated the drug well and found it was effective in controlling symptoms.

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