Senior Regulatory Associate - 12 month contract

Employer
Key People Limited
Location
Uxbridge, London, England
Salary
£20 - £25 per hour
Closing date
23 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
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Within this role you will assist with, under the direction of a Regional Regulatory Lead, the creation and submission of regulatory documents and you may be the regulatory lead for a program under the supervision of a more experienced regulatory lead!

Responsibilities:

- Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations)
- Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
- Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications
- Review regional component of the Global Regulatory Plan and provide input to operational deliverables
- Ensure compliance via timely submissions to regulatory agencies
- Support RRL in review of promotional materials for commercial activities (ex-US)
- Collaborate with CROs / partners to support site initiation
- Coordinate collection of functional documents in support of regulatory applications
- As appropriate participate in GRT to support execution of regulatory strategy
- Coordinate QC of regulatory documentation (e.g. briefing packages)
- Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
- Prepare regulatory packages and cross-reference letters to support investigator initiated studies
- Approve drug shipment for the company and Investigator Initiated Studies
- Complete regulatory forms to support agency communications (E.G. EudraCT,)
- Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
- Support process improvement initiatives, standards development, and metrics
- Assist in template development and maintenance
- Respond to specific requests from and communicate relevant issues to GRT
- Develop Regulatory Position with teams
- Actively support regulatory compliance
- Support the development and execution of GRT goals

Key Skills

- Strong communication skills - oral and written
- Organizational skills
- Understanding of drug development process

For further details, please contact Tim Barratt on +441727 817 626 or email a copy of your CV to tbarratt@keypeople.co.uk

International recruitment solutions

Key People is a truly international operation with offices in the UK, Switzerland and Iraq

We have developed working relationships with many of the FTSE 100 companies, including some of the world's most recognised global brands in the pharmaceutical, Oil, Gas, Energy and engineering industries.

Our dedication to both employers and candidates, and our vast experience enables us to provide superior solutions and effective results. We're proud to be a private company driven by our commitment to our customers and we are constantly exploring new markets in our bid to become the number one recruitment agency for customer satisfaction across a number of industry sectors.

Contact Us
  • Catherine House
  • Adelaide Street
  • St Albans
  • AL3 5BA
  • GB
  • +44 (0) 1727 811634
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