AbbVie Regional Regulatory Submission Specialist in Maidenhead, United Kingdom

Regional Regulatory Submission Specialist

United Kingdom, England, Maidenhead

21 additional locations

United KingdomUnited Kingdom, England, HampshireUnited Kingdom, England, ReadingUnited Kingdom, England, Windsor and MaidenheadUnited Kingdom, England, WitneyUnited Kingdom, England, OxfordshireUnited Kingdom, England, BerkshireUnited Kingdom, England, CroydonUnited Kingdom, England, LondonUnited Kingdom, England, SuttonUnited Kingdom, EnglandUnited Kingdom, England, Kensington and ChelseaUnited Kingdom, England, SloughUnited Kingdom, England, BuckinghamshireUnited Kingdom, England, IslingtonUnited Kingdom, England, Hammersmith and FulhamUnited Kingdom, England, Kingston upon ThamesUnited Kingdom, England, SwindonUnited Kingdom, England, Richmond upon ThamesUnited Kingdom, England, High WycombeUnited Kingdom, England, Surrey

Regulatory Affairs

Requisition #1804478

Senior Regional Regulatory Submission Specialist

Based in the Maidenhead offices or Home based.

Reporting to the Associate Director, Submissions Operations.

Competitive salary, Car allowance, Bonus and comprehensive benefits package.

The company:

AbbVie is an ambitious health business where people and quality of life come first. The experience of illness is personal, so we care about the things that matter to patients. As market leader, we team with partners to co-design health solutions around our innovative medicines for complex diseases, which improve standards of care. Helping people to be fit for work and family life is how we make a remarkable impact to the lives of men, women and children.

The role:

This very exciting role is working in fast paced, busy, but fun department, supporting Regulatory processes and systems in the production and archiving of regulatory submissions.

Highlighted responsibilities:

  • Creation, formatting and filing of documents for electronic submissions to ensure that they are “submission ready”, working with Area and Affiliate regulatory personnel.

  • Perform pre-publishing tasks to ensure timely set up and maintenance supporting the publishing of regulatory submissions (e.g. email, eDocs and Sharepoint folders; submission planners; working folders) including Registration Management tasks, where applicable.

  • Expedite and coordinate a multitude of interrelated activities for a submission team.

  • Assist with co-ordination of publishing carried out by offsite contractors, including support for work allocation, resolution of queries and team review.

  • Perform post-publishing tasks

Qualifications & experience:

  • Experience of working in a regulatory submissions, Publishing or registration management environment

  • IT literate including MS Office, Adobe Acrobat, Documentum / XML

  • Quick to learn new IT systems and processes and the ability to thrive in a changing environment and to re-prioritise workload to meet business needs

  • Good communication skills, both verbal and written

  • Extremely high level of attention to detail and ability to work accurately

For further information and an informal chat, please contact