Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

Senior Regulatory Affairs Officer - office or home based

Company: Quintiles
Location: Reading
Reference: 1717513
Closing Date: 07 Nov 17
Type: Full Time
Salary (£): Negotiable
Benefits:

Job Summary:

This role is a rare opportunity for an experienced regulatory professional with broad regulatory experience and expertise to work with the world’s leading and most creative CRO. This position requires a demonstrable knowledge of operational experience in European regulatory within the service industry, e.g. a CRO, BPO or similar. ...

Requirements:

This role is a rare opportunity for an experienced regulatory professional with broad regulatory experience and expertise to work with the world’s leading and most creative CRO. This position requires a demonstrable knowledge of operational experience in European regulatory within the service industry, e.g. a CRO, BPO or similar.

Our Regulatory Affairs Department works on global projects and covers all regions, where we work on a variety of therapeutic areas and support the biggest pharma companies as well as smaller organizations. You will join a global diverse team that thrives on teamwork and cooperation. Our organization is growing in new projects and broadening the scope of strategic regulatory work.

As part of your responsibilities you will be:

  • Preparing Scientific Advice Packages / Meeting with authorities, PIP submissions, ODD submission and/or coordinate MAA submissions
  • Overseeing the Project management of a European or Global regulatory team
  • Collaborating effectively and meeting with Regulatory Agencies and Clients
  • Ensuring that the Project will stay within budget, the work will complete on-time and deliverables for projects are of high quality
  • Providing strategic insights to support the European team

This is a billable role, therefore expertise to conduct billable project work is required, preferably in the regulatory strategy, pre-MAA area

Skills and Experience required:

You should have extensive experience working in the field of Regulatory Affairs (6+ years) in particular, strong communication and organisation skills, good knowledge on all or some of the following areas:

  • Be familiar with EU Marketing Authorisation Applications and have deep understanding of post authorisation submissions (variations, renewals, transfers etc.)
  • Be able to give Scientific Advice on Regulatory Strategies and have good knowledge of Orphan Drug Designations and Paediatric Investigation Plans
  • Ideally be experienced in the preparation and submission of MAAs, PIPs and ODDs
  • Track record in supporting successful drug development and registration
  • Scientific degree in Pharmacy, biotechnology, chemistry or life science. Higher degrees would be more desirable accompanied by 6+ year’s regulatory affairs operational experience, ideally within the sector.

Education

  • Scientific degree in Pharmacy, biotechnology, chemistry or life science. Higher degrees would be more desirable accompanied by 6+ year’s regulatory affairs operational experience, ideally within the sector.

Apply for this job: Senior Regulatory Affairs Officer - office or home based

Contact Information:

Address:  .
.

England
Website:  Visit Our Web Site

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.