Description
About the Company
Our client is a well-funded, clinical-stage biopharmaceutical company headquartered in California, advancing a pipeline of innovative therapeutics across oncology and rare disease. With multiple programmes in Phase I/II clinical trials and strong investor backing, they are at an exciting inflection point in their growth. They are now seeking a Senior Regulatory Affairs Manager to join their expanding Regulatory team and play a pivotal role in driving their programmes towards IND/BLA/NDA submissions.
The Role
As Senior Regulatory Affairs Manager, you will be responsible for leading regulatory strategy and submissions activities across one or more clinical-stage assets. Reporting to the VP/Head of Regulatory Affairs, you will collaborate cross-functionally with Clinical, CMC, Pharmacovigilance, and Medical Affairs teams to ensure regulatory compliance and support the advancement of clinical programmes.
Key Responsibilities
- Develop and implement global regulatory strategies for clinical-stage assets, with a primary focus on the FDA (IND, BLA/NDA pathways)
- Author, review, and coordinate regulatory submissions including INDs, IND amendments, annual reports, meeting request packages, and briefing documents
- Lead interactions and communications with the FDA, including Type A, B, and C meetings; prepare and review meeting packages and responses
- Provide regulatory guidance and strategic input to cross-functional teams including Clinical Development, CMC, Nonclinical, and Commercial
- Interpret and communicate relevant FDA regulations, guidance documents, and industry standards to internal stakeholders
- Support the development and review of clinical protocols, informed consent forms, and study reports from a regulatory perspective
- Maintain and manage regulatory files and tracking systems to ensure compliance with applicable regulations
- Monitor the regulatory landscape and proactively identify risks and opportunities relevant to the development programmes
- Contribute to due diligence activities and regulatory assessments for business development opportunities
Requirements
- Bachelor's degree or higher in a life sciences discipline (advanced degree preferred)
- Minimum 6+ years of regulatory affairs experience within the pharmaceutical or biopharmaceutical industry
- Demonstrated experience with FDA submissions and interactions across clinical development (IND experience essential; BLA/NDA experience advantageous)
- Strong knowledge of FDA regulations, ICH guidelines, and US drug development pathways
- Experience working in oncology or rare disease therapeutic areas preferred
- Excellent written and verbal communication skills with the ability to craft clear, compelling regulatory documents
- Strong project management skills and ability to manage multiple priorities in a fast-paced, clinical-stage environment
- RAC certification (US) is a plus
What's on Offer
- Competitive base salary commensurate with experience
- Equity participation / stock options
- Comprehensive benefits package including medical, dental, and vision
- Flexible/hybrid working arrangements
- Opportunity to shape regulatory strategy at a pivotal stage of company growth
How to Apply
This role is being exclusively managed by Stirling Q&R Consulting. To find out more or to apply, please submit your CV and a brief cover note via the application form below, or contact us directly at info@stirlingqr.com.