Note: The job is a remote job and is open to candidates in USA. Precision Point seeks a Regulatory Affairs Consultant to provide regulatory strategy and submission support for clinical-stage programs progressing toward Phase III and registration. The role includes FDA and EMA interactions, regulatory writing, BLA readiness, and strategic advice to regulatory leaders and program teams.

Responsibilities

• Regulatory strategy input for programs moving from Phase II toward Phase III and registration
• Preparation of FDA and EMA meeting packages, including briefing documents for End of Phase II, Type B and Type C meetings
• Authoring and review of IND amendments, annual reports, expedited pathway requests and other submissions
• BLA readiness activities, such as gap analyses, submission planning and Module 2 content review
• Health authority question responses and correspondence
• Regulatory intelligence and precedent research for oncology and autoimmune biologics
• Ad hoc strategic advice to the regulatory leader and program teams

Skills

• 10+ years of regulatory affairs experience in biotech, pharma or a regulatory consultancy
• Experience supporting clinical stage programs, with exposure to late stage development and FDA meetings
• Strong regulatory writing skills, including briefing documents and submission content
• Experience with biologics or large molecule therapeutics
• Comfort working independently and flexibly within a lean biotech team
• Phase III, BLA or launch experience
• Oncology, hematology or autoimmune therapeutic area experience
• Experience with antibodies, bispecifics or cell depleting therapies
• EMA and global regulatory experience
• Prior FDA experience or a background in a regulatory consultancy

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