Posts Tagged ‘pharmaceutical company’

Associate Director of Regulatory Affairs Job – London, UK

Wednesday, October 27th, 2010

A global pharmaceutical company is looking for an Associate Director of Regulatory Affairs to join their team based in London, UK.

Reporting to the Regulatory Affairs Director, the main objectives of this Associate Director of Regulatory Affairs include:

  • You will be required to plan, manage and execute regulatory activities related to global regulatory leadership for one or more projects.
  • Provide regional regulatory therapeutic area strategic guidance on development projects and marketed products.

 

Job Responsibilities:

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

  • Manage and hire as necessary therapeutic area product development regulatory affairs staff.
  • Act as regulatory contact person for global project team on selected products.
  • Act as regional therapeutic area regulatory representative for specific project and products.
  • Prepare monthly reports detailing any development activities.
  • Responsible for due diligence and feasibility assessments of candidates in a therapeutic area.

 

Previous experience:

o        Life sciences degree.

o        Previous line management experience.

o        Pharmaceutical industry knowledge essential.

o        Experience within regulatory affairs.

 

Apply Now

For more information, or to apply for this Associate Director of Regulatory Affairs job, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com.

Alternatively, click here to apply for this Associate Director of Regulatory Affairs job online.

 

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Senior Regulatory Director (Emerging Markets) – Hertfordshire, UK

Thursday, August 12th, 2010

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.

Alternatively, click here to apply for this Senior Regulatory Director role online now.

Director of Regulatory Affairs – Berkshire, UK

Wednesday, July 21st, 2010

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.

EU Regulatory Strategist Required for Wordwide Pharmaceutical Company based in the South of England

Tuesday, February 23rd, 2010

Our client, one of the world’s leading pharmaceutical companies is currently looking for an EU Regulatory Strategist to join their team based in the South of England.

Reporting to the EU Regulatory Strategy Portfolio Manager, your role will include:

  • Ensuring EU contribution to Global Regulatory Strategies and implementation plans.
  • Ensuring that the regulatory contributions work towards achieving the objectives in the strategy.
  • Be responsible for providing the required regulatory contributions to project teams, adhering to time and cost deadlines.
  • To liaise with Senior Management regarding regulatory plans.
  • Work closely with the Regulatory Product manager to ensure consistent and appropriate process, working practices and quality standards.

The ideal candidate for this EU Regulatory Strategist role will be educated to a minimum degree level in a scientific subject and will have demonstrable have experience of the following:

  • EU regulations.
  • CTA and MAA submissions process.
  • Management of complex regulatory issues.

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

Alternatively, click here to apply for this EU Regulatory Strategist job

Click here to apply for other Regulatory Affairs jobs.

 

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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