Remote Regulatory Affairs Specialist - Pharmaceutical

Placements24; Bloemfontein; Hybrid; ZAR 600,000 - 1,000,000; Full time

Benefits offered by this job

Remote work flexibility

Competitive compensation

Career growth opportunities

Home office stipend

Job summary

Placements24 is seeking a seasoned Remote Regulatory Affairs Specialist to join a global pharmaceutical team. This fully remote role focuses on managing regulatory submissions across international markets from a home office, with occasional meetings near Welkom if needed.

The ideal candidate has 4–6 years of regulatory affairs experience, a life sciences degree, and a proven track record in CTD/MAA submissions, ICH, FDA, and EMA guidelines.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or related life science.
• 4–6 years of pharmaceutical regulatory affairs experience.
• Proven track record of regulatory submissions and approvals in major markets.
• Strong knowledge of ICH, FDA, and EMA guidelines.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD/MAA/ANDA) to global authorities.
• Interpret international regulations to ensure product compliance.
• Develop regulatory strategies for registration and lifecycle management.
• Collaborate with R&D, manufacturing, quality to gather submission data.
• Monitor evolving regulatory landscapes and advise on impacts.

Skills

Regulatory affairs

CTD submissions

Global submissions

Project management

Education

Pharmacy degree

Regulatory affairs certification

Tools

ICH Guidelines

FDA/EMA knowledge

Job description

About the Role

Our client is seeking a seasoned Remote Regulatory Affairs Specialist to join their global pharmaceutical team. This critical role involves managing the regulatory submission process for new and existing pharmaceutical products across various international markets. You will ensure compliance with global regulatory standards, interpret complex regulations, and develop effective regulatory strategies. This is a fully remote position, offering flexibility and the opportunity to work from anywhere while contributing to bringing essential medicines to patients worldwide from your home office, ideally based near Welkom for occasional team collaboration if needed.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, MAA) to health authorities globally.
• Interpret and apply international pharmaceutical regulations, guidelines, and standards to ensure product compliance.
• Develop and implement regulatory strategies for product registration and lifecycle management.
• Liaise with regulatory agencies, respond to queries, and manage post-approval changes and submissions.
• Collaborate with internal departments, including R&D, manufacturing, and quality assurance, to gather necessary information for submissions.
• Stay abreast of evolving regulatory landscapes and advise the organization on potential impacts.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 4-6 years of experience in pharmaceutical regulatory affairs.
• Proven track record of successful regulatory submissions and approvals in major markets (e.g., US, EU, SA).
• In-depth knowledge of regulatory submission requirements and guidelines (e.g., ICH, FDA, EMA).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently, manage multiple projects simultaneously, and meet strict deadlines in a remote setting.

Benefits

• Highly competitive remote salary and potential for performance bonuses.
• Comprehensive health, dental, and vision insurance plans.
• Generous home office stipend and technology support.
• Significant opportunities for professional development and career growth within a global organization.
• Flexible working hours to accommodate personal needs, ensuring a healthy work-life balance.