Remote Global Regulatory Affairs Manager

Placements24; Roanoke (VA); A distancia; USD 120.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Retirement planning

Travel opportunities

Professional development

Descripción de la vacante

Placements24 is assisting a globally recognized pharmaceutical leader in recruiting a seasoned Pharmaceutical Affairs Manager for a fully remote role. You will drive regulatory strategies, oversee submissions, and ensure compliance across international health authorities from a distributed team.

The ideal candidate has 7+ years in regulatory affairs, an advanced degree, and strong remote leadership and collaboration skills to deliver complex global submissions while coordinating cross-functional

Formación

• Master's degree or PhD in Pharmacy, Chemistry, Biology, or related field.
• 7+ years of progressive experience in pharmaceutical regulatory affairs with global submissions.
• Experience navigating international regulatory environments and health authority requirements.
• Proven ability to lead cross-functional teams remotely and manage complex regulatory projects.

Responsabilidades

• Develop and execute global regulatory strategies for product development and commercialization.
• Manage the preparation, review, and submission of regulatory dossiers to health authorities worldwide.
• Serve as a key point of contact for regulatory agencies, addressing inquiries and facilitating approvals.
• Ensure ongoing compliance with national and international pharmaceutical regulations.
• Provide expert regulatory guidance to R&D, manufacturing, and commercial teams.
• Monitor regulatory intelligence and advise on strategy adjustments.
• Oversee post-approval activities including variations, renewals, and annual reporting.
• Collaborate with international regulatory counterparts to harmonize strategies.
• Contribute to company-wide regulatory policies and procedures.
• Lead and mentor junior regulatory affairs professionals within the remote team.

Conocimientos

Regulatory strategy

Global submissions

Stakeholder leadership

Remote collaboration

Regulatory intelligence

Educación

Master's degree or PhD in a related field

Herramientas

CTD knowledge

Descripción del empleo

Placements24 is assisting a globally recognized pharmaceutical leader in recruiting a seasoned Pharmaceutical Affairs Manager for a fully remote role. You will drive regulatory strategies, oversee submissions, and ensure compliance across international health authorities from a distributed team.

The ideal candidate has 7+ years in regulatory affairs, an advanced degree, and strong remote leadership and collaboration skills to deliver complex global submissions while coordinating cross-functional