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
