Especialista de Asuntos Regulatorios

About the role

The company is seeking a Regulatory Affairs Specialist to manage regulatory processes for pharmaceutical and biopharmaceutical products. The role involves ensuring compliance with local and international health regulations while supporting product registration, renewal, and variation activities.

Key responsibilities

• Prepare and submit health registration dossiers, renewals and variations for pharmaceutical products.
• Maintain up‑to‑date knowledge of Panamanian health legislation (MINSA/DNFD) and international guidelines (ICH, CTD/eCTD, WHO).
• Coordinate regulatory projects, ensuring timelines and quality standards are met.
• Communicate effectively with clients, regulatory authorities and internal teams.
• Monitor regulatory changes and advise on compliance strategies.

Required profile

• Minimum 2 years of experience in regulatory affairs for pharma or biopharma products.
• Proven experience handling registrations, renewals and product variations.
• Strong understanding of Panamanian health regulations and global guidelines.
• Excellent communication skills and ability to work with authorities and clients.
• Detail‑oriented with a focus on compliance and quality.

Required skills

• Knowledge of Panamanian health legislation (MINSA/DNFD).
• Familiarity with international guidelines: ICH, CTD/eCTD, WHO.
• English language proficiency at B2 level or higher.