Posts Tagged ‘Cambridge’

Pharmaceutical Regulatory Affairs Company moves HQ to Cambridge

Wednesday, February 8th, 2012

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.”

Click here to search our regulatory jobs now.

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.

Click here to search our other Regulatory Affairs jobs now.

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 Manager Job – Cambridge, UK

Friday, November 12th, 2010

The main purpose of this Regulatory Affairs Manager job will be to facilitate product development and global registration by helping to develop regulatory strategy for product manufacturing and quality programs from MAA to life cycle management.

 

Main Responsibilities:

  • Preparation of CMC sections for Emerging Markets filings, from MAA to post approval activities.
  • Contribute to CMC product teams, reports status and development of projects to teams and department.
  • Interact with authors and reviewers with respect to conformance of documents to regulatory and CMC requirements.
  • Consider how Emerging Market regional issues effect regulatory strategy for proposed CMC filings.
  • Monitor and assess impact of global regulations, guidance's and current regulatory environment and apply to job.
  • Develop and maintain templates for IE regional requirements.
  • Document CMC submissions and other communications in IMR.
  • Licensing support, may represent regulatory at due diligence meetings.

 

Person Specification:

  • Extensive hands on experience within the pharmaceutical or biotechnology industries.
  • Strong knowledge of regulatory affairs.
  • CMC specific regulatory knowledge and experience.
  • Direct experience with Emerging Market applications.
  • Creation of regional regulatory strategies.
  • Attention to detail.
  • Time and project management skills.
  • Problem solving.
  • Strong written and verbal skills.

 

Apply Now

For more information, or to apply for this Regulatory Affairs Manager job, please contact Meera Pattni at CK Clinical on +44 (0)1438 743047 or email mpattni@ckscience.co.uk.

Senior Regulatory Affairs Manager – Nephrology and Inflammation, based in Cambridge and Uxbridge, UK

Monday, March 15th, 2010

Our client, a leading biotechnology company, is currently looking for an experienced Senior Regulatory Affairs Manager to join their Nephrology and Inflammation Therapeutic Area.

As a Senior Regulatory Affairs manager, your role will be to develop and implement regulatory strategies to expedite global drug development and registration and to manage the execution of regional strategies and regulatory communications and submissions. You will assist in providing expertise on regional regulatory requirements and precedence to interdepartmental teams.

Further key activities of this Senior Regulatory Affairs Manager job will include:

  • Participate through the Global Regulatory Team in the development of product label and core data sheet.
  • Respond to requests from the Global development team and functional areas.
  • Advocate and actively support regulatory compliance.
  • Help to develop regional regulatory strategy for integration into the Global Regulatory Plan.
  • Develop TA expertise.
  • Help resolve any problems on the critical path to regional registration in concert with global registration strategy.

The ideal candidate for this Senior Regulatory Affairs Manager job will be qualified to a minimum Bachelors degree. You will have in-depth experience of Regulatory Affairs Research Development or related area in the Biotech/Pharmaceutical industry, along with experience in inflammation, drug development and CMC knowledge. Line management experience is also desirable.

How to Apply

If you would like to hear more about this Senior Regulatory Affairs Manager job, please contact Meera Pattni on 01438 743047 or email mpattni@ckclinical.co.uk.

Alternatively, click here to apply for this Senior Regulatory Affairs Manager job now.

 

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.

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