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Open nowPosted yesterday

Regulatory Affairs Associate I

MyCareersFuture96,520 open roles

Pay
SGD 3,200 – SGD 4,300 a month
Where
Singapore
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Your applicationOpen nowRegulatory Affairs Associate IMyCareersFuture · Singapore

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Early applications get read.

8.1% of postings close within 7 days. Measured by our own scanner across the market. MyCareersFuture postings stay open a median of 4 days.

Share of postings closed within
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  2. 3.5%3 days
  3. 8.1%7 days
  4. 15.1%14 days
  5. 33.9%30 days
This job: posted yesterday

MyCareersFuture median: 4 days open

The posting

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

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