What are the responsibilities and job description for the Regulatory Affairs Manager – Clinical Development position at Barrington James?
We are seeking an experienced and highly motivated Regulatory Affairs Manager 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 :
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
