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Cmed Clinical Services has appointed Geoff Fatzinger as Vice President of Global Medical and Regulatory Affairs, expected to bring his expertise from fifteen years as a regulatory professional, reports marketwatch.com.
Mr Fatzinger is expected to provide invaluable assistance in developing the new Medical and Regulatory Group established by Cmed, something he did successfully in his previous role at INC Research. Cmed CEO, David Connelly, believes Mr Fatzinger will be “a key building block in [Cmed’s] future business strategy.” He will be responsible for the company’s global Medical and Regulatory department.
Mr Fatzinger has a wealth of experience working with companies in Europe, Asia and North America and has spent his career in various areas around the world promoting and improving regulatory affairs, through his work and through lectures. He has said that “I am looking forward to the challenge, and making Cmed Clinical Services the industry’s first choice in quality partners for product development and product approvals.”
International pharmaceutical companyAlmirall SA has begun its second set of applications for Sativex’s regulatory approval in Europe, reports pharmabiz.com.
Should the application be successful, it will see the drug be separately trialled in a variety of European countries, such as Ireland, Finland, Slovakia and Portugal, amongst others. The response by the EMA is expected to come in the first six months of 2012.
Chief scientific officer at Almirall, Bertil Lindmark, has said that his company “welcome the chance to widen accessibility” to Sativex in relieving the symptoms of spasticity in multiple sclerosis patients. The drug, developed by GW Pharmaceuticals, is also in Phase III clinical trials for the management of cancer pain.
Meera Pattni at CK Regulatory is recruiting for a Senior Regulatory Associate to join a pharmaceutical company based in Buckinghamshire.
As Senior Regulatory Associate you will support the implementation of regulatory operational activities in Emerging Markets in Europe, Middle East and Africa, and provide regulatory support for the registration and maintenance of activities of medicinal products. You will also be required to develop and maintain knowledge of regulatory procedures in the region.
Further responsibilities of this Senior Regulatory Associate position include:
New Product Registration:
Ensure effective implementation of the assembly and preparation of core files for Marketing Authorisation Applications.
Work cross functionally to respond to questions from regulatory authorities to gain product approvals.
Ensure effective planning and tracking of activities.
Ensure effective coordination of the review and approval product related packaging as required, to ensure regulatory compliance.
Support the definition and communication of regulatory strategy in support of new product registration, in line with commercial activities.
Ensure that teams and functional groups are provided with clear, constructive regulatory advice and guidance.
Marketed Product Maintenance:
Provide regulatory support for assigned products and inputs to project teams via Global Regulatory Teams.
Ensure effective implementation of variations and renewals for the region.
Implement regulatory activities in support of lifecycle management and maintenance of the region.
Work with regulatory staff “in country” to support the markets.
Provide clear communication to “in country” and global regulatory staff on planned activities and priorities.
As Senior Regulatory Associate, you will have the following qualifications, skills and experience:
Life sciences degree.
Knowledge of international pharmaceutical regulations and guidelines.
Extensive regulatory affairs experience, including a successful track record in the registration and maintenance of pharmaceutical products within Europe.
Excellent organisation, planning and negotiation skills.
Excellent verbal and written communication skills.
As reported by Business Weekly, the Pharmaceutical Regulatory Affairs organisation, ELC Group has moved their headquarters from Prague to Cambridge, UK.
The Regulatory Consulting and Services provider has moved to the Cambourne Business Park in the hope this will help booster their acquisitions and help them increase their presence in South Asia.
ELC Group grew rapidly in 2011, fuelled by the demand for their regulatory affairs consulting sercices. They have also seen strong customer demand for their Pharmacovigilance and regulatory submissions service.
Marco Rubinstein, CEO of ELC Group, said: “In tough market conditions, we have enjoyed a year of truly outstanding revenue growth. This really demonstrates the value our global customers are deriving from our core offering, and provides an excellent platform for the strategic plans we have in place to expand the breadth and depth of ELC Group’s capabilities.
“The establishment of our new global headquarters provides us with an optimal location from which to execute our growth ambitions and cement our leadership position in the regulatory affairs service market.”
The drug is to be used in patients who cannot take metformin, and the EC approved the drug following clinical studies which proved that the new drug is a successful monotherapy. It was generally well tolerated by those who took part in the study and improved glycemic control by a large degree.
There is a very low risk of hypoglycaemia when using vidagliptin, though it is weight neutral so can be used across the vast majority of patients. The drug is already approved as an add-on to metformin and Timothy Maloney, Novartis’ global business franchise head, believes it to be an effective and generally well-tolerated alternative.
Meera Pattni at CK Regulatory is recruiting for a Senior Manager of Regulatory Affairs to join a large pharmaceutical company based in Hertfordshire. This is a permanent position.
Senior Manager of Regulatory Affairs Job Description:
You will be responsible for clinical trial submission, scientific advice and regulatory input into clinical and drug development plans for developmental and marketed compounds. You will also be responsible for managing MAA submissions for compounds allocated as well as assisting with new pipeline projects and late stage candidates brought in through in licensing.
Further responsibilities of this Senior Manager of Regulatory Affairs role will include:
To support regulatory strategy and manages timelines and resources to meet project needs.
To take responsibility for the quality and completeness of regulatory submissions for Clinical Trial Applications, amendment updates for NCEs and MAAs.
To be responsible for the overall quality and compliance of regulatory submission documents to the appropriate regulatory bodies and act as the day to day contact for regulatory authorities.
To provide input into clinical and drug development plans.
To provide regulatory input and project management for all variations and other submissions for allocated projects.
To provide assistance in making submissions in emerging markets.
To ensure that EU regulatory strategy is addressed and any required submissions are made to agreed timelines.
To organise Regulatory Agency meetings and accompanying briefing documents.
To provide EU regulatory input into IPTs.
To take lead in interacting with regulatory agencies.
As Senior Manager of Regulatory Affairs you will have the following qualifications, skills and experience:
Life sciences degree
Regulatory experience in R&D
In depth knowledge of EU Clinical Trials Directives
Extensive experience of IMPDs, submission of CTAs and EudraCT databases
Extensive experience of the Drug Development process
Experience of providing input into clinical development plans
Through knowledge of and experience of submissions made through MRP, DCP and Centralised Procedure
For more information or to apply, please contact Meera Pattni at CK Regulatory on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23624 in all correspondence.
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.
For more information, please contact Meera Pattni on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23541 in all correspondence.
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.
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:
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.
