Senior Regulatory Submissions Analyst (publishing)
- Experience Level
- Experienced (non-manager)
- Full-time contract position
- ASAP start for minimum 12 month contract
- Remote working initially with some office travel to Buckinghamshire
- Competitive package available
- Global pharma company
- Publishes submissions within the European Region in line with current national and regional requirements for eCTD applications.
- Works with regional archivists to ensure that published submissions are archived in accordance with local and global SOPs.
- Provides guidance (and where necessary training) to European Region Regulatory Affairs staff on all aspects of submission formats/requirements and publishing related software/tools as and when required.
- Builds and maintains relationships with Regulatory and other staff within and outside of the region to ensure effective communication and efficient implementation of regulatory submission strategy and activities.
- Works collaboratively with colleagues within the International Regulatory Submissions Team across the AMEA, Europe and LACAN regions.
- Provides support and mentorship to junior colleagues within the team
Full job description available on application
- Good knowledge of European pharmaceutical regulations and guidelines.
- Experience in publishing CP, MRP and DCP submissions, including eCTD
- Good knowledge and experience of all submission types (MAAs, Variations, Renewals, CTAs, ASRs etc)
- Knowledge/experience in publishing submissions for emerging markets (Middle East, Non-EU Europe etc) would be ideal.
- Experience in eCTDs an NeeS essential
- Ideally experience using Liquent
- Only candidates with existing right to work in the UK/EU will be considered
Please complete the details below to apply. For further information or a discreet discussion regarding your recruitment requirements, please call Alex on 01227 844466 or email email@example.com
To view our other vacancies, please visit our website on www.apexrecruitment.com
Apex Recruitment are a specialist agency providing opportunities within the pharmaceutical, biopharma, biotech and medical device industries recruiting in the areas of medical affairs, drug safety, clinical and quality.
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