Fortrea Hiring Regulatory Submissions Associate Manager II – APAC | Remote Regulatory Affairs Jobs

Fortrea is hiring for the position of Regulatory Submissions Associate Manager II – APAC. This is an excellent opportunity for experienced clinical regulatory professionals looking to advance their careers in a global CRO environment. The role offers a hybrid/remote working model across multiple APAC locations, including India, Australia, Malaysia, and New Zealand.

Job Details

Position: Regulatory Submissions Associate Manager II – APAC
Company: Fortrea
Job Type: Full-Time
Work Mode: Hybrid / Remote
Location: Remote India, Remote Australia, Remote Malaysia, Auckland, and other APAC locations
Job Requisition ID: 263220

About the Role

As a Regulatory Submissions Associate Manager II, you will collaborate with internal stakeholders, clients, and regulatory authorities to ensure timely and compliant regulatory submissions for clinical trial projects across the APAC region. The role involves managing Regulatory Authority (RA), Independent Review Board (IRB)/Ethics Committee (EC), and Third Body submissions while maintaining project timelines and regulatory compliance.

Key Responsibilities

• Oversee and manage RA, IRB/EC, and Third Body submissions for assigned clinical trials.
• Develop submission strategies, timelines, and regulatory plans.
• Track submission and approval milestones and ensure timely completion.
• Coordinate responses to regulatory queries and requests.
• Prepare, review, and quality-check regulatory submission packages.
• Ensure compliance with applicable regulations, guidance documents, and client requirements.
• Provide regulatory advice and expertise to project teams and clients.
• Support interactions with Regulatory Authorities, Ethics Committees, and Third Bodies.
• Review and contribute to study start-up plans and regulatory strategies.
• Monitor project budgets and identify out-of-scope activities.
• Participate in quality assurance, audits, inspections, and risk management activities.
• Attend client meetings, project kick-offs, and regulatory discussions.
• Contribute to process improvement initiatives and SOP development.
• Mentor junior team members and provide regulatory guidance.

Required Qualifications

Education

• Bachelor’s Degree in Life Sciences or an equivalent discipline.
• Relevant industry experience may be considered in lieu of educational requirements.

Experience

• Minimum 4 years of experience in Clinical Trial Regulatory Affairs within the Pharmaceutical or CRO industry.
• Experience managing Regulatory Authority (RA), IRB/EC, and Third Body submissions.
• Strong understanding of submission strategy, planning, and timeline management.
• Expertise in quality control (QC) of regulatory submission packages.
• Knowledge of global and regional clinical trial regulations.
• Excellent communication and stakeholder management skills.
• High attention to detail and organizational abilities.

Preferred Skills

• Experience supporting multi-country APAC clinical trials.
• Knowledge of EU Clinical Trials Regulation (CTR) and CTIS.
• Ability to manage multiple projects simultaneously.
• Strong problem-solving and risk management capabilities.
• Client-facing experience in a CRO environment.

Why Join Fortrea?

• Work with a leading global clinical research organization.
• Opportunity to manage regulatory activities across multiple APAC countries.
• Flexible hybrid and remote work arrangements.
• Exposure to international clinical development programs.
• Career growth and professional development opportunities.

How to Apply

Interested candidates can apply through the official Fortrea careers portal:

Apply Here:
Fortrea Careers

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