Senior Regulatory Affairs Specialist

Placements24; Cape Town; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Bonus potential

Remote healthcare

Home office stipend

Flexible hours

Impact on strategy

Job summary

Placements24 is seeking a Senior Regulatory Affairs Specialist for a fully remote role to guide drug development through global regulatory landscapes, develop strategies, prepare submissions, and interact with health authorities worldwide.

The ideal candidate has a Master’s or PhD in a scientific field, 7+ years in regulatory affairs, proven success across major markets, and excellent communication, capable of leading projects autonomously from a home office.

Qualifications

• Masters or PhD in a scientific field.
• 7+ years of regulatory affairs experience.
• Proven track record of successful regulatory submissions and approvals.
• Expert knowledge of international guidelines (ICH, SAHPRA, FDA, EMA).
• Excellent written and verbal communication skills.
• Ability to work autonomously and manage multiple projects remotely.

Responsibilities

• Develop and implement global regulatory strategies for drug development.
• Prepare, review, and submit regulatory dossiers to health authorities worldwide.
• Liaise with regulatory agencies (SAHPRA, FDA, EMA) to address inquiries and facilitate approvals.
• Provide regulatory guidance to R&D, clinical, and commercial teams.
• Monitor evolving guidelines and advise on compliance.
• Conduct regulatory due diligence for collaborations and acquisitions.

Skills

Regulatory affairs

Communication

Autonomous work

Education

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

Job description

About the Role

Our client, a forward-thinking pharmaceutical company, is actively seeking a dedicated Senior Regulatory Affairs Specialist to join their fully remote team. In this pivotal role, you will be instrumental in guiding drug development programs through complex regulatory landscapes across various global markets. You will develop and execute regulatory strategies, prepare and submit regulatory applications, and serve as the primary point of contact with health authorities. This position offers an exceptional opportunity for a seasoned professional to shape regulatory pathways for innovative therapies from the comfort of their home office, contributing to a company culture that champions innovation, compliance, and employee well-being.

Key Responsibilities

• Develop and implement comprehensive global regulatory strategies for drug development programs.
• Prepare, review, and submit regulatory dossiers, including INDs, NDAs, and variations, to health authorities worldwide.
• Liaise directly with regulatory agencies (e.g., SAHPRA, FDA, EMA) to address inquiries and facilitate approvals.
• Provide regulatory guidance and support to R&D, clinical, and commercial teams throughout the product lifecycle.
• Monitor and interpret evolving regulatory guidelines and advise the organization on compliance requirements.
• Conduct regulatory due diligence for potential collaborations and acquisitions.

Requirements

• Master's or PhD in Pharmacy, Chemistry, Biology, or a related scientific discipline.
• Minimum of 7 years of experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals in major markets.
• Expert knowledge of international regulatory guidelines (ICH, SAHPRA, FDA, EMA).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work autonomously and manage multiple projects in a remote work environment .

Benefits

• Highly competitive salary with excellent bonus potential.
• Comprehensive remote health, dental, and vision benefits.
• Generous provision for home office setup and professional development.
• Flexible working hours to accommodate a remote-first lifestyle.
• Significant impact on product development and company strategy.