Regulatory Professional

Industriebereich:
Pharma
Currency:
£
Ort:
Vereinigtes Königreich
Gehalt:
€1 per day
Veröffentlicht:
13/09/2021
Stellenreferenz:
CR/106821

One of my biggest clients within the pharmaceutical market in the UK is looking for someone to join their Regulatory Team!!

Job title: Regulatory Professional

Location: Uxbridge (possibility to WFH)

Contract: 12 months (Inside IR35)

Main tasks:

- Creation and submission of regulatory documents and be the regulatory lead for a program under the supervision of a more experienced regulatory lead

- 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

- Review regional component of the Global Regulatory Plan and provide input to operational deliverables

- Collaborate with CROs / partners to support site initiation

- Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)

Key Skills:

- Strong communication skills - oral and written

- Understanding of drug development process

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Kontaktangaben:
Telefon: 020 7739 2022
Kontakt: Claudia de Cesaris
E-Mail:

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