Senior Regulatory Submissions Analyst (publishing)

DETAILS:

• 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

THE ROLE:

• 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

THE CANDIDATE:

• 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

TO APPLY:

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 alex@apexrecruitment.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.