Remote Global Regulatory Affairs Leader

Placements24; Willows (CA); Remote; USD 140,000 - 190,000; Full time

Benefits offered by this job

Remote-first environment

Health insurance

Retirement contributions

Performance bonuses

Flexible schedule

Career development

Job summary

Placements24 is seeking an experienced Regulatory Affairs Manager to lead regulatory strategies for a pharmaceutical portfolio from a fully remote capacity. You will oversee global submissions, liaise with health authorities, and guide product development, ensuring compliance across markets.

The role emphasizes independence, strong communication, and mentorship as the team grows. A Master’s or PhD in a related field and at least 8 years of regulatory experience are required, with fluency in

Qualifications

• Advanced degree in a scientific discipline (Master's or PhD).
• Minimum 8 years of pharmaceutical regulatory affairs experience.
• Proven track record of successful regulatory submissions and approvals.
• Deep knowledge of ICH guidelines, CTD format, and regional regulatory procedures.

Responsibilities

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

Skills

Strategic thinking

Analytical skills

Problem solving

Communication

Negotiation

Independent work

Education

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

Job description

Placements24 is seeking an experienced Regulatory Affairs Manager to lead regulatory strategies for a pharmaceutical portfolio from a fully remote capacity. You will oversee global submissions, liaise with health authorities, and guide product development, ensuring compliance across markets.

The role emphasizes independence, strong communication, and mentorship as the team grows. A Master’s or PhD in a related field and at least 8 years of regulatory experience are required, with fluency in