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Senior Regulatory Associate - 12 month contract

Job Field:
Regulatory and Drug Safety Jobs
Discipline:
Regulatory Affairs Jobs
Country:
United Kingdom
Region:
London
Contract Type:
Temp / Locum / Contract
Currency:
£
Salary:
20 to 25 per hour
Posted:
03-Dec-20
Recruiter:
Key People
Job Ref:
BBBH22381

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

Closing Date:
11/12/2020

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