Remote Regulatory Affairs Leader – Global Submissions

Placements24; Klerksdorp; Hybrid; ZAR 1,000,000 - 1,800,000; Full time

Benefits offered by this job

Executive-level salary

Remote-first role

Professional development opportunities

Job summary

Placements24, a respected pharmaceutical entity, seeks a seasoned Regulatory Affairs Manager for a fully remote role. You will navigate global regulatory landscapes, shape submission strategies, and ensure compliance across markets while coordinating with R&D, manufacturing, and commercial teams.

This role demands a Master’s or PhD in a scientific field, 7+ years in regulatory affairs, and a proven track record of successful submissions (SAHPRA, FDA, EMA).

Qualifications

• 7+ years of progressive regulatory affairs experience.
• Proven track record of successful submissions and approvals in major markets (SAHPRA, FDA, EMA).
• In-depth knowledge of ICH and global submission requirements.
• Strong communication and negotiation skills.
• Ability to work independently in a remote setting.

Responsibilities

• Develop and execute regulatory strategies for product registrations and lifecycle management.
• Prepare and submit regulatory dossiers (e.g., CTD) to health authorities in various regions.
• Interpret and communicate regulatory requirements to stakeholders.
• Act as the liaison with regulatory agencies for submissions.
• Review promotional materials for regulatory compliance.
• Manage post-approval changes and product registrations.
• conducts regulatory intelligence to stay updated on legislation.
• Collaborate with R&D, manufacturing and commercial teams.

Skills

Regulatory strategy

CTD submissions

Regulatory intelligence

Cross-functional coordination

Regulatory compliance

Education

Master's or PhD in Pharmaceutical Science

Tools

Regulatory information systems

CTD format

Job description

Placements24, a respected pharmaceutical entity, seeks a seasoned Regulatory Affairs Manager for a fully remote role. You will navigate global regulatory landscapes, shape submission strategies, and ensure compliance across markets while coordinating with R&D, manufacturing, and commercial teams.

This role demands a Master’s or PhD in a scientific field, 7+ years in regulatory affairs, and a proven track record of successful submissions (SAHPRA, FDA, EMA).