Regulatory Affairs Manager

The Regional Regulatory Affairs Project lead is responsible for leading end-to-end regulatory strategies and execution across multiple markets to support product registration and lifecycle management. This role drives cross-functional alignment, ensures timely submissions and approvals, and acts as the key regulatory point of contact for assigned products/portfolios within the region.

Job Responsibilities

Regulatory Strategy & Execution

• Develop and implement regional regulatory strategies to support product registration, approval, and lifecycle management across APAC and/or assigned markets.
• Lead end-to-end submission planning, ensuring alignment with business timelines and regulatory requirements.
• Provide strategic input on regulatory pathways (e.g., reliance, accelerated pathways, bridging strategies) to optimize approval timelines.
• Anticipate regulatory risks and proactively develop mitigation plans.

Project Leadership & Cross-Functional Collaboration

• Serve as the RA project lead, coordinating with cross-functional teams (e.g., Medical, QA, Supply Chain, Commercial, BD) to drive project execution.
• Lead cross-functional team (CFT) discussions to ensure alignment on regulatory strategy, timelines, and deliverables.
• Act as the primary regulatory interface with internal stakeholders and external partners/licensors.

Submission Management

• Oversee preparation, review, and submission of regulatory dossiers (e.g., CTD/eCTD) across multiple markets.
• Ensure high-quality documentation and compliance with local regulatory requirements.
• Track submission progress and manage responses to health authority queries in a timely manner.

Stakeholder & Health Authority Engagement

• Provide regulatory guidance to internal teams and external partners.
• Support or lead interactions with health authorities where applicable (e.g., meetings, responses to queries).
• Build and maintain effective working relationships with local affiliates and regulatory agencies.

Regulatory Intelligence & Compliance

• Monitor and interpret evolving regulatory requirements and industry trends across the region.
• Provide timely regulatory intelligence and assess impact on ongoing and future projects.
• Ensure all activities are compliant with internal SOPs and external regulatory requirements.

Job Specification

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• 5-7 years of experience in regulatory affairs, preferably within the pharmaceutical, biotechnology, or medical device industry.
• Familiarity with regional regulatory requirements (e.g., ASEAN, ICH, PIC/S) is a plus.
• Exposure to different product types (Rx, generics, OTC, devices) is an advantage.
• Strong documentation and organizational skills; detail-oriented with a proactive mindset.
• Effective communication and collaboration skills, with the ability to work across cultures and time zones.
• Ability to work collaboratively in a cross-functional and multicultural environment.