EPM Scientific
Senior Manager Global Regulatory Affairs
EPM Scientific, San Diego, California, United States, 92189
Overview
A clinical stage biotech organization is seeking a
Manager/Senior Manager Regulatory Affairs
to support 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. Base pay range : $140,000.00/yr - $190,000.00/yr 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. 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. Experience with international regulatory submissions. Familiarity with tools such as Veeva RIM and SmartSheets. Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Other Industries: Pharmaceutical Manufacturing Location: San Diego, CA Get notified about new Manager Global Regulatory Affairs jobs in
San Diego, CA . #J-18808-Ljbffr
A clinical stage biotech organization is seeking a
Manager/Senior Manager Regulatory Affairs
to support 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. Base pay range : $140,000.00/yr - $190,000.00/yr 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. 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. Experience with international regulatory submissions. Familiarity with tools such as Veeva RIM and SmartSheets. Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Other Industries: Pharmaceutical Manufacturing Location: San Diego, CA Get notified about new Manager Global Regulatory Affairs jobs in
San Diego, CA . #J-18808-Ljbffr