Regulatory & Pharmacovigilance Junior Officer

About the role

Labatec Pharma is seeking a motivated Junior Officer to support its Regulatory Affairs team in Sintra. You will assist in ensuring compliance with local regulatory requirements and pharmacovigilance obligations while contributing to the company’s growth.

Key responsibilities

• Monitor product texts and ensure alignment with reference products.
• Manage regulatory intelligence, preparation, submission and publication of professional and patient information.
• Review packaging materials and support quality activities such as change requests and PQRs.
• Request CPPs for export markets and maintain regulatory databases and trackers.
• Assist in the implementation and maintenance of pharmacovigilance procedures, literature screening, and audit preparation.
• Provide timely medical information responses and manage the MIR database.
• Update internal SOPs for regulatory affairs, pharmacovigilance and medical affairs.

Required profile

• Degree in Life Sciences (PharmD, PhD, MSc preferred).
• 1‑2 years of experience in regulatory affairs, pharmacovigilance, medical affairs or related functions.
• Understanding of Good Pharmacovigilance Practices (GVPs).
• Excellent communication skills and ability to work cross‑functionally.
• Fluent English (C1‑C2); French or German is a plus.

Required skills

• Knowledge of GVPs.
• Regulatory intelligence processes.
• Pharmacovigilance procedures and documentation.

What we offer

• A collaborative and friendly environment within a human‑size company.
• Opportunities to develop expertise in regulatory and pharmacovigilance fields.
• Exposure to both hospital and retail pharmaceutical sectors.