Regulatory Affairs Specialist - Biologics

About the Role

Our client is seeking a knowledgeable and experienced Regulatory Affairs Specialist with a focus on Biologics to join their progressive team. This is a fully remote position, offering the flexibility to contribute to global regulatory strategies from anywhere. You will be responsible for preparing, reviewing, and submitting regulatory documentation for biologic products, ensuring compliance with international regulations and guidelines. This role is critical in bringing innovative biologic therapies to patients worldwide and requires a deep understanding of regulatory pathways for complex biological products.

• Prepare and submit high-quality regulatory submissions for biologics (e.g., INDs, BLAs, variations) to health authorities globally.
• Review and interpret new and existing regulatory guidelines and regulations impacting biologic product development and approval.
• Liaise with internal departments (e.g., R&D, Manufacturing, Quality) to gather necessary information for submissions.
• Serve as a primary contact with regulatory agencies during the review process.
• Develop regulatory strategies for the development and lifecycle management of biologic products.
• Maintain regulatory compliance for assigned products throughout their lifecycle.

• Bachelor's degree in a scientific discipline (e.g., Biology, Biochemistry, Pharmacy) or related field.
• Master's or Ph.D. is a plus.
• Minimum of 4 years of experience in regulatory affairs, specifically with biologics.
• In-depth knowledge of global regulatory requirements for biologics (FDA, EMA, etc.).
• Experience preparing and submitting major regulatory filings (e.g., BLA).
• Excellent technical writing and communication skills.
• Ability to work independently and manage multiple projects in a remote setting.

• Competitive salary and comprehensive benefits package.
• Fully remote work environment, promoting work-life balance.
• Significant opportunities for career advancement within a growing regulatory affairs department.
• Exposure to a diverse portfolio of innovative biologic products.
• A collaborative and intellectually stimulating remote work culture supporting professional growth across Eastern Cape.