Regulatory Affairs Associate

Posted 7 November by Kelly Services
Kelly Scientific are working with a leading life sciences organisation who are looking for a Regulatory Affairs Associate to join on a 12 month contract which has the potential to be extended. 

The successful candidate will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.

Further 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 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
- Collaborate with CRO's / partners to support site initiation
- Coordinate collection of functional documents in support of regulatory applications
- As appropriate, 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

Requirements:
- Life Sciences degree essential 
- Proven regulatory knowledge (2 years+) especially CMC for worldwide submissions is required for this role 
- Experience of document management systems is highly advantageous 
- Strong communication skills - oral and written
- Understanding of drug development process

Reference: 33735474

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