Senior regulatory affairs specialist

Senior Regulatory Affairs Consultant
Key Responsibilities
Global Regulatory Submissions & Lifecycle Management
Lead the preparation, compilation, review, and submission of regulatory dossiers to global health authorities including US FDA, EMA, MHRA, TGA, HSA, NPRA, Thai FDA, Taiwan FDA, CDE, NMPA, PMDA, and other international agencies.
Perform comprehensive dossier gap assessments across CTD Modules 1–5, ensuring completeness, compliance, and submission readiness.
Author, convert, and manage submissions in e CTD, ACTD, and CTD formats in accordance with regional regulatory requirements.
Drive end-to-end regulatory submissions for ANDAs, NDAs, BLAs, MAAs, and associated lifecycle activities including variations, renewals, responses, transfers, and withdrawals.
Coordinate and manage responses to regulatory agency queries by collaborating with CMC, Clinical, Non-Clinical, Quality, and Manufacturing stakeholders.
Ensure regulatory compliance and submission quality through a strong understanding of CMC, clinical, non-clinical, and administrative documentation requirements.
Regulatory Project Management
Manage multiple regulatory projects and submissions across diverse geographies and product portfolios simultaneously.
Develop and monitor submission plans, timelines, milestones, and deliverables to ensure on-time execution.
Utilize project management tools and tracking mechanisms to maintain visibility and mitigate submission risks.
Act as the key liaison between global regulatory teams, regional affiliates, cross-functional stakeholders, and clients to ensure seamless project execution.
Support regulatory strategy development and provide guidance on submission pathways, agency requirements, and lifecycle management activities.
Required Qualifications & Experience
Bachelor's or Master's degree in Pharmacy, Life Sciences, Biotechnology, or a related discipline.
8–10 years of hands-on Regulatory Affairs experience supporting submissions across regulated markets, APAC, and Rest of World (ROW) regions.
Strong expertise in global regulatory frameworks, dossier preparation, submission processes, and lifecycle management.
Proven experience handling complex, multi-country regulatory submissions and coordinating cross-functional teams.
Excellent stakeholder management, communication, and project management skills.
Experience with electronic submission platforms and document management systems is highly preferred.