Submission Project Management
Regulatory Operations & Publishing
Quality & Compliance

Overview: Join a Regulatory Affairs team supporting the preparation, coordination, and delivery of regulatory submissions. The role is responsible for managing low- to medium-impact submission projects, coordinating cross-functional stakeholders, maintaining submission timelines, and ensuring dossiers meet regulatory authority technical requirements.

Location: Singapore

Key Responsibilities

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 multiple concurrent submission activities and support delivery of published submissions within required timelines.
Maintain submission content planners, timelines, and publishing readiness.

Regulatory Operations & Publishing

Provide Submission Management support and guidance to project teams regarding established submission processes and standards.
Coordinate publishing activities with external publishing vendors and resolve publishing-related issues.
Prepare submission content for publishing and facilitate procurement or creation of required submission deliverables such as cover letters and forms.

Quality & Compliance

Perform detailed quality reviews of published outputs to ensure compliance with regulatory standards and health authority guidance.
Verify content accuracy, bookmarks, hyperlinks, and tables of contents within submission packages.

Stakeholder Collaboration & Continuous Improvement

Participate in submission team meetings and collaborate with cross-functional stakeholders.
Contribute to the development and implementation of publishing processes, standards, and business process improvements.
Build strong relationships internally and externally while influencing stakeholders without direct authority.

Requirements

Bachelor's degree or equivalent qualification. Relevant experience may compensate for lower educational qualifications.
Experience within the pharmaceutical industry or a related sector.
Experience working in a complex, matrixed environment.
Strong verbal and written communication skills.
Regulatory Affairs experience preferred; candidates from Quality Assurance, 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.

Preferred Skills

PMP certification.
RAC (Regulatory Affairs Certification).
Regulatory submission publishing knowledge.
Process improvement and project coordination experience.

We regret to inform that only shortlisted candidates will be notified.

Job Reference: R25150511 Cammy Li Xin Hui

Allegis Group Singapore Pte Ltd, Company Reg No. 200909448N, EA License No. 10C4544

Regulatory Affairs Associate