Global Regulatory Affairs Lead - Remote US

MMS; Raleigh (NC); A distancia; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

MMS Holdings Inc is seeking a seasoned Regulatory Strategy professional to lead regulatory submissions and strategy across US and international teams. The role emphasizes oversight of eCTD workflows, risk assessment, and ensuring regulatory readiness for IND, NDA/BLA/MAA activities.

Candidates should bring 5+ years in regulatory strategy, deep knowledge of ICH guidelines, and strong collaboration with clinical and project teams. Remote work is supported for US-based applicants.

Formación

• Minimum of 5 years’ experience in Regulatory Strategy or similar field required.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.

Responsabilidades

• Serves as regulatory strategy lead for US and global submissions, coordinating across regions.
• Oversees eCTD submission planning, compiling regulatory documents and ensuring timely delivery.
• Provides strategic input and technical guidance on regulatory requirements to project teams.
• Acts as POC for US regulatory submissions and coordinates with international authorities.
• Supports sponsor meetings with the FDA and advisory committees; conducts regulatory research as needed.

Conocimientos

Regulatory strategy

ICH guidelines expertise

Regulatory submissions

FDA/regulatory knowledge

Regulatory project leadership

Problem solving

Herramientas

MS Office

Adobe Acrobat

SharePoint

eCTD viewer

Descripción del empleo

MMS Holdings Inc is seeking a seasoned Regulatory Strategy professional to lead regulatory submissions and strategy across US and international teams. The role emphasizes oversight of eCTD workflows, risk assessment, and ensuring regulatory readiness for IND, NDA/BLA/MAA activities.

Candidates should bring 5+ years in regulatory strategy, deep knowledge of ICH guidelines, and strong collaboration with clinical and project teams. Remote work is supported for US-based applicants.