Job Description

A clinical stage biotech organization is seeking a Manager/Senior Manager Global Regulatory Affairs to supports multiple international regulatory initiatives across clinical-stage programs. This company is pioneering RNA interference-based therapeutics to address serious diseases with high unmet medical need. Its innovative platform enables targeted delivery to specific tissues, allowing for precise gene silencing and durable therapeutic effects.

The successful candidate will lead regulatory planning and submissions, ensure compliance with global regulatory standards, and collaborate cross-functionally to align strategies and timelines. This position offers broad exposure to regulatory operations and strategic development activities.

Key Responsibilities

• Lead the preparation and submission of global regulatory documents (e.g., INDs, CTAs/IMPDs, annual reports, briefing packages).
• Support or lead preparations for regulatory authority interactions.
• Partner with global and regional regulatory teams, including external consultants, to support marketing authorization applications.
• Develop and maintain submission plans, content outlines, and responsibility matrices to ensure consistency and completeness.
• Track key milestones and deliverables to meet submission timelines.
• Interpret and communicate regulatory requirements to ensure compliance across development activities.
• Provide regulatory guidance to internal teams, with frequent collaboration with technical and clinical functions.
• Review scientific and technical documentation for regulatory alignment.
• Stay current with evolving regulatory frameworks and maintain internal knowledge resources.

Qualifications

• BS or MS degree with 5+ years of hands-on regulatory experience, or
• PharmD or PhD with 3+ years of hands-on regulatory experience.
• Strong understanding of ICH and FDA guidelines, particularly related to device and combination product CMC aspects.
• Experience managing complex projects in a matrixed, collaborative environment.
• Excellent communication and negotiation skills across organizational levels.
• Detail-oriented with the ability to work independently and within cross-functional teams.
• Proven success in fast-paced, entrepreneurial settings.
• Experience with international regulatory submissions.
• Familiarity with tools such as Veeva RIM and SmartSheets.

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