Global Regulatory Affairs Manager — Remote Strategy Lead

Placements24; Redmond (WA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive benefits

Remote work arrangements

Job summary

Placements24 is seeking a Regulatory Affairs Manager to lead global regulatory efforts from a remote-based position. This role requires developing regulatory strategies, preparing dossiers, and engaging with health authorities to drive timely approvals and market access.

The ideal candidate will have 8+ years in pharmaceutical regulatory affairs, deep knowledge of ICH and GxP guidelines, and strong communication and negotiation skills to influence product development and compliance worldwide.

Qualifications

• Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field.
• 8+ years of progressive pharmaceutical regulatory affairs experience.
• Experience preparing and submitting regulatory applications in US, EU, and other major markets.
• In-depth knowledge of pharmaceutical regulations, ICH guidelines, and GxP.
• Excellent written and verbal communication skills with ability to negotiate with health authorities.

Responsibilities

• Develop and implement global regulatory strategies for product registration and lifecycle management.
• Prepare and submit regulatory dossiers (CTD, NDA, ANDA) to health authorities worldwide.
• Interpret and advise on regulatory requirements and their impact on development and commercialization.
• Liaise effectively with regulatory agencies, providing timely responses to inquiries and facilitating approvals.
• Ensure compliance with applicable regulations, guidelines, and company policies.
• Monitor changes in the regulatory landscape and update strategies accordingly.

Skills

Regulatory strategy

Dossier preparation

Regulatory submissions

Health authority liaison

Communication & negotiation

Education

Bachelor's degree in Pharmacy

Advanced degree preferred

Job description

Placements24 is seeking a Regulatory Affairs Manager to lead global regulatory efforts from a remote-based position. This role requires developing regulatory strategies, preparing dossiers, and engaging with health authorities to drive timely approvals and market access.

The ideal candidate will have 8+ years in pharmaceutical regulatory affairs, deep knowledge of ICH and GxP guidelines, and strong communication and negotiation skills to influence product development and compliance worldwide.