Regulatory Affairs Lead

1 week ago

Singapur, Singapore Ambiway Associates Full time

Regulatory Affairs Lead (Associate Director – Director Level), Vaccines Job Title: Regulatory Affairs Lead (Associate Director – Director Level), Vaccines Location: China or Singapore Reports to: Head of International R&D Center Company Overview: Our client is a well-established biopharmaceutical company dedicated to the research, development, and global commercialization of innovative vaccines and biologics. With a rapidly growing international presence, the company is strengthening its regulatory affairs team to support global registration and market access initiatives. Position Overview: The RA Lead will take charge of global and regional regulatory affairs for vaccine products, leading the planning and execution of registration strategies across key international markets. This role requires a seasoned regulatory professional with at least 10 years of hands‑on registration experience, ideally in vaccine or biologics projects, and a strong working relationship with regulatory agencies such as FDA, EMA, and Singapore Health Sciences Authority (HSA). Key Responsibilities: Develop and execute international regulatory and registration strategies for vaccine products. Manage preparation, review, and submission of dossiers (IND, CTA, BLA, MAA, etc.) to global regulatory authorities. Lead communication and negotiation with agencies including FDA, EMA, HSA, and other regional authorities. Provide regulatory guidance for global clinical development and CMC teams to ensure compliance with international standards. Monitor global regulatory changes and provide strategic input to senior management. Build and maintain cross‑functional collaboration across R&D, Clinical, and Manufacturing teams. Mentor and manage junior regulatory staff to ensure high‑quality submissions and efficient project delivery. Qualifications: Master’s degree or above in Pharmacy, Biotechnology, Life Sciences, or a related field. Minimum 10 years of regulatory affairs experience, preferably in vaccines or biologics. Proven experience leading regulatory submissions and interactions with FDA, EMA, and HSA (Singapore). Strong understanding of drug registration requirements in Southeast Asia, Europe, and/or the U.S. Excellent communication, leadership, and stakeholder management skills. Fluent English; additional Chinese language skills are advantageous. #J-18808-Ljbffr

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