Regulatory Affairs Specialist - SME

Job title: Regulatory Affairs SME - Biosimilars

Location: Argentina (Remote)

Contract Duration: 6-12 months

Company Overview:

Apsida Life Science is partnering with a leading global clinical research organization (CRO) that supports pharmaceutical, biotechnology, and medical device companies throughout the product development lifecycle. The organization provides end-to-end services across clinical research, regulatory consulting, market access, pharmacovigilance, medical communications, and commercialization.

Key Responsibilities:

• Provide subject matter expertise on biosimilar regulatory requirements in Argentina.
• Advise on local regulatory pathways and requirements for biosimilar products.
• Support the preparation, review, and submission of regulatory documentation to the relevant Health Authority.
• Ensure compliance with current Argentine regulatory requirements and applicable guidelines.
• Review regulatory strategies and identify potential risks or gaps.
• Collaborate with global and cross-functional teams to provide local regulatory insights.
• Respond to regulatory queries and provide scientific and regulatory recommendations as needed.

Requirements:

• Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, Medicine, or a related scientific discipline (advanced degree preferred).
• 5+ years experience in Regulatory Affairs within the pharmaceutical or biotechnology industry.
• Demonstrated expertise in biosimilars, including development, registration, lifecycle management, or regulatory strategy.
• Strong knowledge of Argentine regulatory requirements and interactions with ANMAT.
• Experience preparing or reviewing biosimilar regulatory submissions.
• Excellent written and verbal communication skills in Spanish; English proficiency is required for collaboration with global teams.
• Ability to work independently in a remote, project-based environment.
• Previous experience supporting multinational pharmaceutical or biotechnology companies.
• Familiarity with ICH guidelines and international regulatory frameworks.

If you are interested in learning more, please reach out to KG Mphahlele at Apsida Life Science:

[email protected]

+44 744 134 1041

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost-effective, high-quality, and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.