Regulatory Affairs Specialist - Pharmaceuticals

Placements24; Durban; On-site; ZAR 1,437,000 - 2,395,000; Full time

Benefits offered by this job

Remote work stipend

Home office setup support

Job summary

Placements24 in Durban is seeking a Regulatory Affairs Specialist to join a remote, globally focused team. You will prepare, submit, and manage regulatory filings, ensuring compliance with SAHPRA, FDA, EMA and other authorities while guiding product development.

This role rewards meticulous, independent professionals who can coordinate cross-functional teams and monitor evolving regulations to support market access for innovative medicines in international markets.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Biology or related discipline.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• Experience preparing and submitting regulatory filings to SAHPRA, FDA and EMA.
• Remote work capability with strong written and verbal communication.

Responsibilities

• Prepare, review, and submit regulatory dossiers (CTD, IND, NDA) to health authorities in international markets.
• Ensure compliance with global regulatory requirements and lifecycle guidance.
• Maintain regulatory submission documentation including amendments and annual reports.
• Liaise with R&D, Quality Assurance, Marketing and external agencies to facilitate approvals.

Skills

Regulatory affairs

Education

Bachelor's degree in Pharmacy

Master's degree or equivalent experience

Job description

About the Role

Our client is seeking a highly organized and detail-oriented Regulatory Affairs Specialist to join their dynamic team. This position is fully remote, allowing you to contribute from anywhere while playing a crucial role in ensuring our pharmaceutical products meet all global regulatory standards. You will be responsible for preparing, submitting, and managing regulatory filings, maintaining compliance, and staying updated on evolving regulations. This is a fantastic opportunity for a motivated professional to shape regulatory strategies and facilitate market access for innovative medicines, working within a forward-thinking company that embraces remote collaboration and values its employees' contributions to public health.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, IND, NDA) to health authorities in various international markets.
• Ensure compliance with global regulatory requirements, guidelines, and standards for pharmaceutical products throughout their lifecycle.
• Maintain and update regulatory submission documentation, including amendments, supplements, and annual reports.
• Liaise with internal departments (e.g., R&D, Quality Assurance, Marketing) and external regulatory agencies to facilitate the approval process.
• Monitor and assess the impact of new or revised regulations on the company's products and submissions.
• Provide regulatory guidance and support to cross-functional teams during product development and lifecycle management.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related scientific discipline; Master's degree or equivalent experience preferred.
• Minimum of 5 years of experience in pharmaceutical regulatory affairs.
• Proven experience in preparing and submitting regulatory filings to major health authorities (e.g., SAHPRA, FDA, EMA).
• In-depth knowledge of global pharmaceutical regulatory landscapes and guidelines.
• Excellent analytical, written, and verbal communication skills.
• Ability to work independently, manage multiple projects, and meet strict deadlines in a remote setting.

Benefits

• Competitive annual salary and potential for performance-based bonuses.
• Comprehensive health insurance coverage and retirement savings plan.
• Generous remote work stipend and support for home office setup.
• Opportunities for professional development and continuing education.
• Flexible working hours to support work-life balance in a remote capacity.