Regulatory Submissions Associate I

ALLEGIS GROUP SINGAPORE PRIVATE LIMITED

Singapore

Sur place

SGD 60 000 - 110 000

Plein temps

14 jours+

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Résumé du poste

Allegis Group Singapore Pte Ltd is seeking a Regulatory Affairs professional to manage submission projects, coordinate cross-functional teams, and ensure dossiers meet regulatory authority requirements in a complex, matrixed environment.

The role emphasizes strong communication skills, proficiency in regulatory operations, and the ability to drive publishing processes with internal teams and external vendors.

Qualifications

  • Bachelor’s degree or equivalent qualification required.
  • Experience in the pharmaceutical industry or related sector preferred.
  • Experience in a complex, matrixed environment.
  • Strong verbal and written communication skills.
  • Regulatory Affairs experience preferred; candidates from QA, R&D Support, Scientific Affairs, Operations, or related disciplines may also be considered.
  • Experience in Regulatory Operations, regulatory submission project management, and/or submission publishing is preferred.
  • Demonstrated leadership capability and stakeholder management skills.

Responsabilités

  • Submission Project Management: Manage low- to medium-impact regulatory submission projects to ensure timely delivery of high-quality dossiers that meet regulatory authority technical specifications.
  • Coordinate concurrent submission activities and support delivery within required timelines.
  • Maintain submission content planners, timelines, and publishing readiness.

Connaissances

Regulatory affairs
Project management
Stakeholder management
Quality assurance

Formation

Bachelor's degree or equivalent

Description du poste

Allegis Group Singapore Pte Ltd is seeking a Regulatory Affairs professional to manage submission projects, coordinate cross-functional teams, and ensure dossiers meet regulatory authority requirements in a complex, matrixed environment.

The role emphasizes strong communication skills, proficiency in regulatory operations, and the ability to drive publishing processes with internal teams and external vendors.

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