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Senior Clinical Submissions Manager - Paddington, London (Hybrid)

Contract: Permanent Career Opportunity

Closing Date: 26/07/24

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A senior position in GDD Regulatory Affairs Operations responsible for managing the delivery of cross-functional submission documentation, overseeing publishing activities, and dispatch of compliant, complex worldwide regulatory submissions in support of global product portfolios

The Role

Duties may include:

  • Manage multiple, large, and complex global regulatory submission projects in eCTD and non-eCTD [e.g., NDA/BLA/INDs, MAAs (CP, MRP, Nees), HA AtoQ, compliance submissions, etc.] efficiently, accurately and simultaneously.
  • Key contributor in submission management activities related to acquisitions, partnerships, and divestitures, key supporter of regulatory agency inspections, and other miscellaneous regulatory operational activities.
  • Provides expert guidance to project teams related to worldwide HA submission structure/format/requirements, submission filing strategy, and eCTD document lifecycle management and submission compilation workflows.
  • Lead, coach, and mentor peers and colleagues.
  • Develops and authors training materials and leads efforts to implement training to ensure optimal use of templates, processes, and tools critical related to regulatory submission activities.
  • Expert advisor in evaluation, selection, and implementation of technologies and processes related to submission planning, publishing, assembly, and archiving (as needed).
  • Submission Management Representative on key internal initiatives, Health Authority meetings, and various industry forums/conferences, as required.
  • Strong ability to troubleshoot and assess technical/quality issues relating to compilation, validation, and dispatch of global submission outputs with accuracy.

Requirements

How to Apply

For further details, please send your CV to: talent@gandlhealth.com

G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuse. All employees at G&L share the responsibility to challenge discriminatory behavior and promote equality of opportunity.

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