Senior Regulatory Affairs Manager - Remote

Placements24; Pretoria; Hybrid; ZAR 1,200,000 - 2,100,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Paid time off

Home office stipend

Professional development

Job summary

Placements24 is seeking a Senior Regulatory Affairs Manager for a fully remote role. You will guide global regulatory strategies, prepare and submit dossiers, and serve as the primary regulatory liaison with agencies such as FDA, EMA, and SAHPRA.

The ideal candidate will have 10+ years in regulatory affairs, strong strategic thinking, and the ability to mentor junior staff in a remote team environment. This position offers a remote-first setup with international collaboration.

Qualifications

• Advanced degree (Master's or Ph.D.) in a scientific discipline or equivalent experience.
• Minimum of 10 years of pharmaceutical regulatory affairs experience.
• Proven track record of regulatory submissions and approvals in major markets (US, EU, SA).
• In-depth knowledge of ICH guidelines, FDA, EMA, and SAHPRA regulations.
• Strong strategic thinking and analytical skills with excellent communication.
• Ability to lead initiatives within a remote team and manage multiple projects.

Responsibilities

• Develop and execute regulatory strategies for product development, registration, and lifecycle management.
• Prepare, review, and submit regulatory dossiers (INDs, NDAs, MAAs, CTAs) to health authorities worldwide.
• Serve as the primary point of contact for regulatory agencies and manage communications.
• Interpret evolving regulatory guidelines and policies.
• Collaborate with R&D, Clinical Operations, QA, and Commercial to ensure regulatory alignment.
• Conduct regulatory intelligence to identify opportunities and risks.
• Oversee post-approval activities including variations, renewals, and annual reports.
• Contribute to strategic planning from a regulatory perspective.
• Ensure compliance with regulations and company policies.
• Mentor junior regulatory professionals.

Skills

Regulatory affairs

Regulatory strategy

Cross-functional collaboration

Global submissions

RIM systems

Education

Master's or PhD in science

Tools

RIM systems

Job description

About the Role

Our client, a dynamic and rapidly growing biopharmaceutical company, is actively seeking a highly accomplished Senior Regulatory Affairs Manager to join their fully remote team. This position is crucial for guiding the company through the complex landscape of global drug development and commercialization. You will be responsible for developing and implementing regulatory strategies for a diverse portfolio of pharmaceutical products, ensuring compliance with all relevant national and international health authority regulations. This role demands a strategic thinker with a proven track record in successful regulatory submissions and interactions with agencies such as the FDA, EMA, and SAHPRA. As a remote-first position, you will leverage advanced communication and collaboration tools to work effectively with internal stakeholders and external partners across different time zones. The successful candidate will play a pivotal role in shaping the regulatory pathway for innovative therapies, contributing significantly to patient access to critical medicines.

Key Responsibilities

• Develop and execute comprehensive regulatory strategies for product development, registration, and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs, CTAs) to health authorities worldwide.
• Serve as the primary point of contact for regulatory agencies, managing all communications and inquiries.
• Interpret and advise on the implications of evolving regulatory guidelines and policies.
• Collaborate closely with cross-functional teams, including R&D, Clinical Operations, Quality Assurance, and Commercial, to ensure alignment on regulatory requirements.
• Conduct regulatory intelligence gathering and analysis to identify opportunities and mitigate risks.
• Oversee and manage post-approval regulatory activities, including variations, renewals, and annual reports.
• Contribute to the strategic planning and decision-making processes from a regulatory perspective.
• Ensure compliance with all applicable regulations and internal company policies.
• Mentor and guide junior regulatory affairs professionals.

Requirements

• Advanced degree (Master's or Ph.D.) in a scientific discipline (e.g., Pharmacy, Biology, Chemistry) or equivalent experience.
• Minimum of 10 years of progressive experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals in major markets (e.g., US, EU, South Africa).
• In-depth knowledge of global regulatory requirements, including ICH guidelines, FDA, EMA, and SAHPRA regulations.
• Strong strategic thinking and analytical skills with the ability to assess complex regulatory issues.
• Excellent written and verbal communication skills, with exceptional attention to detail.
• Demonstrated ability to build and maintain strong relationships with health authorities and internal stakeholders.
• Experience in managing multiple projects simultaneously in a fast-paced environment.
• Proficiency in regulatory information management (RIM) systems.
• Ability to work independently and lead initiatives within a remote team structure.

Benefits

• Excellent annual salary of R.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and flexible working hours.
• Retirement savings plan with substantial employer match.
• Opportunities for professional growth, training, and attendance at international conferences.
• Home office setup allowance and ongoing technical support.
• Direct impact on bringing innovative therapies to patients globally.
• Collaborative and supportive virtual work environment.