Job Description

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!

To apply:

kwilson@barringtonjames.com

Direct line: +44 1293 223 951

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