Regulatory & Pharmacovigilance Junior Officer

About the role

Labatec Pharma is seeking a dynamic and motivated Regulatory & Pharmacovigilance Junior Officer to join its Regulatory Affairs team in Sintra. The role provides operational support to regulatory, pharmacovigilance and medical activities, ensuring compliance with local requirements and company standards.

Key responsibilities

• Monitor product texts and ensure alignment with reference products.
• Manage the regulatory intelligence process.
• Prepare, submit and publish professional and patient information on relevant platforms.
• Review packaging materials (AWs) and support quality change requests.
• Request CPPs for export markets and maintain regulatory databases and trackers.
• Update internal regulatory affairs SOPs.
• Support pharmacovigilance activities, including literature screening.
• Assist in implementing and maintaining PV procedures and compliance activities.
• Prepare documentation for PV inspections and audits, and follow up on outcomes.
• Provide timely medical information responses across markets.
• Maintain and manage the MIR database and update internal PV and Medical Affairs SOPs.

Required profile

• Degree in Life Sciences (PharmD, PhD, MSc preferred).
• 1‑2 years of experience in Pharmacovigilance, Medical Affairs, Regulatory Affairs or related scientific/regulated functions.
• Understanding of Good Pharmacovigilance Practices (GVPs).
• Excellent communication skills and ability to convey medical, scientific, legal and regulatory topics.
• Fluent English (C1‑C2); French or German is an advantage.

Required skills

• Good Pharmacovigilance Practices (GVPs)

What we offer

• A collaborative and friendly environment within a human‑size company.
• Opportunity to grow in an established, agile pharmaceutical organization.