Remote Global Regulatory Affairs Manager

Placements24; United States; Remote; USD 140,000 - 200,000; Full time

Benefits offered by this job

Health insurance

Retirement contributions

Remote-first culture

Job summary

Placements24 is actively seeking an experienced Regulatory Affairs Manager to steer regulatory strategy across global markets in a fully remote capacity. You will guide product development, submissions, and post-market activities to ensure compliant, timely approvals and safe, effective medicines for patients worldwide.

The role requires senior expertise, strong leadership, and the ability to liaise with health authorities (FDA, EMA, SAHPRA) while supporting cross-functional teams in a

Qualifications

• Advanced degree (Master's or PhD) in Pharmacy, Chemistry, Biology, or related field.
• 8+ years in pharmaceutical regulatory affairs with global knowledge.
• Proven track record of successful regulatory submissions and approvals.
• In-depth knowledge of ICH guidelines, CTD format, and regional procedures.
• Experience managing product lifecycle, including post-approval changes.
• Excellent strategic thinking, analytical, and problem-solving skills.
• Exceptional communication, negotiation, and interpersonal skills.
• Ability to work independently and manage multiple projects remotely.
• Fluency in English; knowledge of other languages is a plus.

Responsibilities

• Develop and implement global regulatory strategies for pharmaceutical product registration and lifecycle management.
• Prepare, review, and submit regulatory dossiers (CTD, NDA, ANDA) to health authorities worldwide.
• Liaise with agencies including SAHPRA, FDA, and EMA to address queries and facilitate approvals.
• Monitor evolving regulatory landscapes, guidelines, and legislation.
• Provide regulatory guidance to R&D, manufacturing, and marketing.
• Manage post-approval regulatory activities (variations, renewals, annual reports).
• Oversee regulatory review of promotional materials and labeling.
• Conduct regulatory intelligence to identify opportunities and risks.
• Lead and mentor junior regulatory staff as the team grows.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Communication & negotiation

Education

Master's or PhD in Pharmacy, Chemistry, Biology or related

Job description

Placements24 is actively seeking an experienced Regulatory Affairs Manager to steer regulatory strategy across global markets in a fully remote capacity. You will guide product development, submissions, and post-market activities to ensure compliant, timely approvals and safe, effective medicines for patients worldwide.

The role requires senior expertise, strong leadership, and the ability to liaise with health authorities (FDA, EMA, SAHPRA) while supporting cross-functional teams in a