Regulatory Affairs Associate I

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