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Job Details

Senior Regulatory Affairs Associate

Company: TEC Group International
Location: Hertfordshire, UK
Reference: CG76995
Closing Date: 26 Nov 17
Type: Permanent
Salary (£): On Application
Benefits: Additional benefits on offer

Job Summary:

The business that I am working with is a small, privately owned Regulatory Affairs and Pharmacovigilance consultancy based in Hertfordshire. Established just over 10 years ago, this consultancy have built a strong reputation throughout the industry globally for being able to provide a high quality service and being able to work in a true partnership with their clients.

Requirements:

Job Title: Senior Regulatory Affairs Associate

Location: Hertfordshire, UK

Salary: Negotiable depending on experience. Up to £50,000 + benefits

 

The Company

The business that I am working with is a small, privately owned Regulatory Affairs and Pharmacovigilance consultancy based in Hertfordshire. Established just over 10 years ago, this consultancy have built a strong reputation throughout the industry globally for being able to provide a high quality service and being able to work in a true partnership with their clients. Not only do this consultancy carry out hands on submission activity for their clients, they also work as true consultants helping their clients to devise global, business critical regulatory strategies, design and implement companywide procedural changes and drive business growth.

The Opportunity

As a Senior Regulatory Affairs Associate within this growing consultancy, you will:

  • Independently manage all aspects of a range of national and pan-European regulatory projects and assignments for primarily medicinal products, biologicals, medical devices, cosmetics and borderline substances.
  • Assist the Regulatory Project Managers to ensure tasks and projects are delivered on schedule and to a high standard of quality.
  • Provide guidance and direction to other regulatory project team members
  • Strengthen and enhance the reputation that this business has for providing high quality regulatory consultancy services.
  • You’ll work across regulatory affairs as a whole, managing Marketing Authorisation Applications, Clinical Trial Applications, Type I and II variations, PIL and labelling amendments, Change of Ownership applications, Renewals, PSUR submissions, Orphan Drug Applications, Paediatric Investigational Plans and technical files

The Person

We are looking for an experienced Regulatory Affairs professional with a passion for what they do. We are not expecting you to know everything so if you have particular expertise in MAA’s and post market maintenance but no clinical experience, or vice versa, then please do still apply. This is a good opportunity for you to further develop your skillset and get involved with other types of submissions in different geographies.

It is essential that you are personable, commercially minded and able to fit in well to a small, close-knit team. As this is a client facing role, you will be able to communicate clearly and effectively.

Application

To find out more about this opportunity or to put yourself forward for consideration either apply to this advertisement or email me on Christopher.gibson@tecgroup.net. Alternatively you could call me on 0208 544 3421.

Apply for this job: Senior Regulatory Affairs Associate

Contact Information:

Address:  Head Office
Dowgate Hill House, 14-16 Dowgate Hill, London
EC4R 2SU
England
Tel:  +44 (0) 208 544 3400
Website:  Visit Our Web Site

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