Regulatory & Pharmacovigilance Junior Officer

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Valuing People. Science.

Life - At Labatec Pharma, we are committed to deliver medicines that help to improve quality of life for patients around the world by meeting the needs of the hospital and retail sectors. We collaborate all together to deliver outcomes which add significant value to our clients' projects and the community as a whole. Our people are at the center of Labatec Pharma.

Labatec is looking for talented individuals to join its growing team! Join us!

We are currently looking for a Regulatory & Pharmacovigilance Junior Officer to join our Regulatory Affairs Team. The role is based in Sintra, reporting to our Regulatory Affairs Manager. We are looking for a dynamic and motivated person, who can support our growth ambitions and add knowledge, competence, and team spirit, to provide operational support to RA, PV and Medical activities ensuring compliance with local regulatory requirements and pharmacovigilance obligations.

Your key responsibilities:

Regulatory Affairs Support

• Monitor product texts in accordance with the reference product.
• Manage the Regulatory intelligence process.
• Manage the preparation, submission and publication of Professional and Patient Information in the respective plataforms.
• Revision of Packaging materials (AWs).
• Support Quality for Change Requests, PQRs, and other activities.
• Request CPPs for the export markets.
• Maintain regulatory databases, trackers updated.
• Maintain and update internal RA SOPs.

Pharmacovigilance and Medical Affairs Support

• Support pharmacovigilance activities including literature screening.
• Assist in the implementation and maintenance of Pharmacovigilance procedures and compliance activities.
• Assist in the preparation of pharmacovigilance inspections and audits by preparing documentation and supporting follow-up activities.
• Ensure timely and compliant Medical Information responses across all markets.
• Maintenance and management of the MIR database.
• Maintain and update internal PV and Medical Affairs SOPs.

We are looking for:

• Degree in Life Science, advanced degree preferably (PharmD, PhD, MSc).
• 1-2 years of relevant experience in Pharmacovigilance, Medical Affairs, Regulatory Affairs, or related scientific/regulated functions.
• Understanding of GVPs.
• Proven ability to understand and clearly communicate medical, scientific, legal and regulatory topics to internal and external stakeholders.
• Excellent communication skills and ability to work cross‐functionally.
• Fluent in English (level C1-C2)
• Fluent in French or German (level C1-C2) is an advantage

We will offer you:

• A collaborative and friendly environment within a human-size company
• An established Company operating with agility
• Continuous professional training to develop your potential
• A rewarding compensation & benefits package

If you are interested in this opportunity, please send your CV to [email protected]

About us

Labatec is a Swiss-based private pharmaceutical company, headquartered in Geneva, Switzerland. Our company has 60+ years experience in the production and supply of medicines to 11 countries comprising Switzerland, the Middle East and North Africa and expanding today in Europe. We aim to be a leading licensing partner in generic and specialty innovative medicines in our markets with an extensive portfolio of 70+ products in both the retail and hospital segments.

We serve our communities by developing, manufacturing, and distributing high quality medicines covering major therapeutic areas such as musculo-skeletal, ophthalmology, anaesthetics, oncology, anti-infectives and women's health.

For more information, please visit our website: