We are seeking an experienced and highly motivated Senior Manager, Regulatory Affairs to support our expanding portfolio in the oncology area. This is an exciting opportunity to play a critical role in regulatory strategy and compliance for a fast-growing organization.
Key Responsibilities:
Develop and implement regulatory strategies for chemical and biological modalities to support clinical development and product registration in the US and globally.
Lead regulatory submission activities, including Pre-IND, IND, NDA/BLA, and other life-cycle management filings.
Ensure the preparation and delivery of high-quality regulatory documents.
Drive Health Authority interactions, including preparing briefing books, coordinating rehearsals, and developing risk mitigation plans.
Collaborate cross-functionally to align regulatory activities with program goals and timelines.
Maintain expert knowledge of FDA, EMA, and ICH guidelines and the evolving regulatory landscape.
Ensure compliance with regulatory requirements and support auditing/inspections.
Provide regulatory leadership to internal teams and external partners.
Qualifications:
Bachelor's degree in a relevant scientific field (e.g., Chemistry, Biochemistry, Molecular Biology, Biotechnology, Biology, Pharmacy); advanced degree preferred.
Minimum of 5 years of regulatory affairs experience in pharmaceutical clinical development.
Strong expertise in FDA, EMA, and ICH regulatory guidelines and processes.
Proven track record of successful regulatory milestones in product development and registrations.
Experience in direct communication and negotiations with regulatory agencies.
Strong organizational skills with meticulous attention to detail.
Excellent communication and leadership skills with a proactive approach.
Ability to work independently and collaboratively within a dynamic environment.
Flexibility to accommodate working across global time zones, including some evening meetings.
Proficiency in English; Mandarin language skills are a plus.
If you are a results-driven regulatory professional looking for an opportunity to make a significant impact, we encourage you to apply today!