EPM Scientific
A dynamic, clinical-stage biotech organization is actively seeking a
Manager/Senior Manager of Regulatory Affairs
to be instrumental in advancing multiple international regulatory initiatives within our innovative RNA interference-based therapeutic programs. This pioneering company addresses serious diseases with high unmet medical needs through cutting-edge technology that enables precise gene silencing and targeted delivery to specific tissues. In this key role, you will take charge of regulatory planning and submissions, ensuring adherence to global regulatory standards while collaborating cross-functionally to align strategies and timelines. This position promises extensive exposure to regulatory operations and strategic development efforts. Key Responsibilities Lead the preparation and submission of global regulatory documents such as INDs, CTAs/IMPDs, annual reports, and briefing packages. Support or take the lead in preparations for meetings with regulatory authorities. Collaborate with global and regional regulatory teams, including external consultants, to facilitate marketing authorization applications. Develop and maintain submission plans, content outlines, and responsibility matrices to guarantee consistency and thoroughness. Monitor key milestones and deliverables to ensure timely submissions. Interpret and communicate regulatory requirements to ensure compliance throughout development activities. Provide regulatory expertise and guidance to internal teams, working closely with technical and clinical functions. Review scientific and technical documentation to ensure alignment with regulatory standards. Stay updated on evolving regulatory frameworks and maintain comprehensive internal knowledge resources. Qualifications BS or MS degree with 5+ years of regulatory experience, or PharmD or PhD with 3+ years of relevant experience. Proven experience managing complex projects in a collaborative, matrixed environment. Exceptional communication and negotiation skills at all organizational levels. Detail-oriented, with the ability to work both independently and as part of cross-functional teams. Experience with international regulatory submissions is highly desirable. Familiarity with tools like Veeva RIM and SmartSheets is a plus.
Manager/Senior Manager of Regulatory Affairs
to be instrumental in advancing multiple international regulatory initiatives within our innovative RNA interference-based therapeutic programs. This pioneering company addresses serious diseases with high unmet medical needs through cutting-edge technology that enables precise gene silencing and targeted delivery to specific tissues. In this key role, you will take charge of regulatory planning and submissions, ensuring adherence to global regulatory standards while collaborating cross-functionally to align strategies and timelines. This position promises extensive exposure to regulatory operations and strategic development efforts. Key Responsibilities Lead the preparation and submission of global regulatory documents such as INDs, CTAs/IMPDs, annual reports, and briefing packages. Support or take the lead in preparations for meetings with regulatory authorities. Collaborate with global and regional regulatory teams, including external consultants, to facilitate marketing authorization applications. Develop and maintain submission plans, content outlines, and responsibility matrices to guarantee consistency and thoroughness. Monitor key milestones and deliverables to ensure timely submissions. Interpret and communicate regulatory requirements to ensure compliance throughout development activities. Provide regulatory expertise and guidance to internal teams, working closely with technical and clinical functions. Review scientific and technical documentation to ensure alignment with regulatory standards. Stay updated on evolving regulatory frameworks and maintain comprehensive internal knowledge resources. Qualifications BS or MS degree with 5+ years of regulatory experience, or PharmD or PhD with 3+ years of relevant experience. Proven experience managing complex projects in a collaborative, matrixed environment. Exceptional communication and negotiation skills at all organizational levels. Detail-oriented, with the ability to work both independently and as part of cross-functional teams. Experience with international regulatory submissions is highly desirable. Familiarity with tools like Veeva RIM and SmartSheets is a plus.